Haemorrhoid Surgery

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PROSPECT Haemorrhoid Surgery Subgroup

For each review, a Subgroup of the prospect Working Group performs an initial evaluation of the evidence and also drafts clinical practice statements and recommendations, which are then discussed by the whole Working Group before a final consensus is reached. The Subgroup may sometimes include a non-Working Group member, to provide additional expertise in the procedure being reviewed. For the haemorrhoid surgery review, the Subgroup members were:

Professor Girish Joshi (PROSPECT Working Group member)

Professor Edmund Neugebauer (PROSPECT Working Group member)

Grades of Recommendation

Recommendations are graded according to the overall level of evidence (LoE) on which the recommendations are based, which is determined by the quality and source of evidence:

Levels of evidence and grades of recommendation in PROSPECT reviews (from 2006)

PROSPECT provides clinicians with supporting arguments for and against the use of various interventions in postoperative pain based on published evidence and expert opinion. Clinicians must make judgements based upon the clinical circumstances and local regulations. At all times, local prescribing information for the drugs referred to must be consulted.

Summary Recommendations

Pre-, intra- and postoperative interventions have been evaluated for the management of postoperative pain following haemorrhoid surgery. Unless otherwise stated, ‘pre-operative’ refers to interventions applied before surgical incision, ‘intra-operative’ refers to interventions applied after incision and before wound closure, ‘postoperative’ refers to interventions applied at or after wound closure. After haemorrhoid surgery, pain is not only related to the early postoperative period, but is also a problem after 2–3 days, around the time of first defecation. The following peri-operative interventions for haemorrhoid surgery have been reviewed:

Pre-operative recommendations for Haemorrhoid Surgery

Intra-operative recommendations for Haemorrhoid Surgery

Postoperative recommendations for Haemorrhoid Surgery

Not recommended for Haemorrhoid Surgery

See Overall PROSPECT recommendations for the overall strategy for managing pain after haemorrhoid surgery.

PROSPECT overall recommendations for postoperative pain management following haemorrhoid surgery:

Recommended for postoperative analgesia:

Overall PROSPECT Recommendations for Haemorrhoid Surgery

Not recommended for postoperative analgesia:

Not recommended for Haemorrhoid Surgery

Description of studies

Literature search

  • Systematic review of the literature from 1966–June 2006 using MEDLINE and EmBASE, following the protocol of the Cochrane Collaboration Haemorrhoid Surgery June 2006 Search Terms
  • Inclusion of randomised studies in English, assessing analgesic interventions in haemorrhoid surgery in adults, and reporting pain on a linear analogue, verbal or numerical rating scale
    • Primary outcome measure: postoperative pain scores
    • Secondary outcome measures: supplemental analgesic requirements, other recovery outcomes (adverse effects, functional recovery)
  • Identification of 207 studies of peri-operative interventions for postoperative pain following haemorrhoid surgery
  • 106 studies included Haemorrhoid Surgery June 2006 Included References
  • 101 studies excluded Haemorrhoid Surgery June 2006 Excluded References
  • The most common reasons for exclusion were that the method of haemorrhoid removal was not surgical (35 studies), or pain scores were not reported (24 studies), or the study was not a randomised controlled trial (29 studies; see Table 1 below) Haemorrhoid Surgery June 2006 Reasons for Exclusion

Study quality assessments, levels of evidence and grades of recommendation

Recommendations are graded according to the overall level of evidence (LoE) on which the recommendations are based, which is determined by the quality and source of evidence: Levels of evidence and grades of recommendation in PROSPECT reviews (from 2006)

Click here for quality scores and levels of evidence for included procedure-specific studies: Haemorrhoid Surgery June 2006 Quality Scoring + Levels of Evidence

Quantitative analyses

No meta-analyses were performed due to a limited number of studies of homogeneous design that reported similar outcome measures. Therefore, the procedure-specific evidence was only assessed qualitatively.

Transferable evidence

Transferable evidence of analgesic efficacy from comparable procedures (e.g. anorectal surgery) or evidence of other outcomes, such as adverse effects, has been included to support the procedure-specific evidence where this is insufficient to formulate the recommendations. Several studies that were identified in the literature search reported data pooled from patients undergoing mixed surgical procedures including haemorrhoid surgery. Such studies are excluded from the procedure-specific systematic review, but have been used as additional transferable evidence in cases where the Working Group considered it appropriate.

Descriptions of haemorrhoid surgery

Operative techniques

  • Open (Milligan-Morgan technique): dissection of the haemorrhoid and ligation of the vascular pedicle, wounds are left open to heal naturally
  • Closed
    • Conventional closed (Ferguson’s technique): the wound is closed with a continuous suture to promote healing
    • Stapled: reduces the prolapse of haemorrhoidal tissue by excising a band of the prolapsed anal mucosa membrane above the dentate line, using a specific circular stapling device. This interrupts the blood supply to the haemorrhoids and reduces the potential for available rectal mucosa to prolapse. May also be referred to as stapled haemorrhoidopexy or stapled anopexy
    • Submucosal (Park’s technique): removes the vascular pedicle corresponding to every haemorrhoidal nodule and preserves the overlying mucosa, which is then accurately reconstructed

Dissection techniques

  • Conventional scissors
  • Diathermy: uses high current bipolar electrocautery for cutting and haemostasis
    • Ligasure™ vessel sealing system: complete haemostasis is achieved by reforming the collagen and elastin in vessel walls to form an autologous seal
  • Harmonic Scalpel: ultrasonically-activated scalpel, associated with decreased thermal damage to tissue and facilitated dissection within tissue planes
  • Radiofrequency bistoury: cuts and coagulates tissues in an atraumatic manner, using radio waves (maximum temperature 80 °C). Eliminates diffuse bleeding because all vessels of 1.5–2 mm diameter are coagulated on the sectioning line, thus haemostasis is controlled
  • Laser: concentrates the energy from electromagnetic radiation into a narrow beam that can be used for cutting, and causes very little damage to the surrounding tissue. It has a coagulative haemostatic effect that allows a dry operative field and obviates the need for ligation or diathermy

Adjuncts to surgery

  • Sphincterotomy: part of the internal sphincter muscle is cut, which relieves the tension of the muscle
  • Anal dilator: widens the anal canal if it has become narrowed because of tightness or spasm in the muscles (anal sphincters) that control the opening and closing of the anus

Topics for future research

In certain circumstances, recommendations for a type of treatment cannot be made due to limited or conflicting evidence. Areas which have been identified as requiring further investigation in the future are listed:

  • Gabapentinoids
  • Ketamine
  • Flavonoids
  • Botulinum toxin injection
  • Topical therapies, including glyceryl trinitrate (GTN) and calcium channel blockers, and haemostatic dressings, including calcium alginate dressing

Abbreviations

CPM

chlorpheniramine maleate

EMLA  

Eutectic Mixture of Local Anaesthetic

GA

general anaesthetic

GTN

glyceryl trinitrate

IM

intramuscular

Intra-op

intra-operatively

IV

intravenous

LA

local anaesthetic

LIS

lateral internal sphincterotomy

MFF

micronized flavonoid fraction

MPFF  

micronized purified flavonoid fraction

NRS    

numerical rating scale

PACU

post-anaesthesia care unit

PCA    

patient-controlled analgesia

POD

postoperative day

PONV  

postoperative nausea and vomiting

Postop

postoperatively

Pre-op

pre-operatively

VAS    

visual analogue scale

VIS      

visual intensity scale

VRS    

verbal rating scale

Pre-operative studies

To ensure an adequate analgesic effect in the immediate postoperative period, it may be necessary to administer analgesic medication prior to the postoperative period.

Data in this section are available from studies that assessed pre-operative analgesia versus pre-operative placebo, as well as those that assessed pre-operative analgesia versus the same analgesia given postoperatively (to examine the concept of pre-emptive – or preventive – analgesia).

A meta-analysis of studies comparing pre-operative interventions with similar postoperative interventions in various procedures found that pre-operative NSAIDs and local anaesthetic wound infiltration improved analgesic consumption and time to first rescue analgesic request, but not pain scores. Evidence did not support an improvement in postoperative analgesia following administration of pre-operative NMDA antagonists and opioids (Ong 2005b). A previous systematic review of pre-emptive analgesia for acute or chronic postoperative pain relief in a variety of surgical procedures — such as orthopaedic, dental, gynaecological and abdominal — has concluded that there is no benefit of pre-emptive over postoperative administration (Møiniche 2002).

PROSPECT recommendations

  • Pre-operative gabapentinoids cannot be recommended (Grade D, LoE 4) because there is no procedure-specific evidence and because the benefit:risk ratio is not sufficiently favourable for this ambulatory procedure, despite analgesic efficacy in other procedures (transferable evidence, LoE 1)

Clinical practice

  • None cited

Transferable evidence

  • Three systematic reviews and a meta-analysis evaluated the use of gabapentinoids for postoperative analgesia and demonstrated significant reductions in postoperative pain and supplementary analgesic requirements compared with inactive controls (
  • Two systematic reviews (
  • Two systematic reviews (

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Based on transferable evidence showing analgesic efficacy (LoE 1), it is recommended (Grade B) that systemic conventional NSAIDs should be administered at the appropriate time to provide sufficient analgesia in the early recovery period
  • There is not enough evidence at this time to recommend the use of one NSAID over another
  • The use of conventional NSAIDs should depend upon assessment of individual patient risks (Grade B), including bleeding complications, actual or recent gastroduodenal ulcer history (transferable evidence, LoE 1), cardiovascular morbidity (LoE 4), aspirin-sensitive asthma, renal function and hepatic function (transferable evidence, LoE 3)

Clinical practice

  • The risk of bleeding complications from haemorrhoid surgery with pre-operative conventional NSAIDs is not a concern, as haemorrhoid surgery is a short, ambulatory procedure, and bleeding complications are minimal
  • Conventional NSAIDs should be administered at the appropriate time to provide sufficient analgesia when the patient wakes

Transferable evidence

  • Conventional NSAIDs have proven analgesic efficacy in a variety of surgical procedures (
  • In a randomized controlled trial of patients undergoing anorectal surgery, patients experienced less pain and required fewer rescue analgesics when treated with pre-operative ketorolac (either IV or as an infusion with a local anaesthetic solution) than when treated with placebo
  • A meta-analysis of randomised controlled trials that was performed to evaluate the risk of morphine-related adverse effects in patients treated with NSAIDs demonstrated that NSAIDs decreased the incidence of nausea, vomiting and sedation, but not pruritus, urinary retention or respiratory depression (
  • One randomised trial in patients undergoing vaginal hysterectomy or breast surgery showed that diclofenac was as effective as rofecoxib in terms of postoperative analgesia, but was associated with greater use of anti-emetics and more blood loss 
  • Two meta-analyses comparing pre-incisional and post-incisional NSAIDs/COX-2-selective inhibitors have found no significant benefit of pre-incisional administration for reducing pain scores (
  • Randomised endoscopic trials in healthy elderly volunteers have shown that COX-2-selective inhibitors are associated with a lower incidence of upper gastrointestinal ulceration compared with conventional NSAIDs for short-term use (
  • Randomised trials in healthy volunteers showed that conventional NSAIDs (ketorolac, naproxen or diclofenac) reduced the platelet aggregation response compared with placebo; ketorolac and naproxen also prolonged bleeding time compared with placebo (
  • Meta-analyses of randomised controlled trials showed that peri-operative conventional NSAIDs increased the risk of postoperative bleeding requiring treatment and/or the risk of re-operation for haemostasis after tonsillectomy compared with controls (
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction
  • A randomised controlled trial showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) were associated with a similar incidence of surgical site bleeding after elective surgery
  • Aspirin and conventional NSAIDs can induce asthma attacks in patients with aspirin-exacerbated respiratory disease (
  • Conventional NSAIDs and COX-2-selective inhibitors have been associated with an increased risk of transient hepatotoxicity. Cases of acute hepatic failure have also been reported (with lumiracoxib; (
  • Short-term use of conventional NSAIDs or COX-2-selective inhibitors can increase the risk of transient renal impairment, especially in patients with existing renal dysfunction, and both types of agent have been associated with cases of acute renal failure in high-risk patients (
  • Chronic administration of conventional NSAIDs and COX-2-selective inhibitors may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication (

Haemorrhoid surgery-specific evidence

  • There were no significant differences between groups receiving IV or caudal ketorolac in VAS pain scores when sitting or supine at any time-point assessed (i.e. at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 10 and 24 h) (
  • There were no significant differences between groups receiving IV or caudal ketorolac in the proportion of patients requiring IV pethidine injection, the number of pethidine doses requested, or the time to first request for rescue analgesia (
  • The incidence of bleeding disorders was significantly lower with caudal ketorolac compared with IV ketorolac (p=0.0098) (
  • The incidence of gastric upsets was significantly lower with caudal ketorolac versus IV ketorolac (p=0.0444) (
  • Study details Yosry 2004 Click here for more information

PROSPECT Recommendation

  • Based on transferable evidence showing analgesic efficacy (LoE 1), it is recommended (Grade B) that COX-2-selective inhibitors should be administered at the appropriate time to provide sufficient analgesia in the early recovery period
  • It is recommended that the use of COX-2-selective inhibitors should depend upon assessment of individual patient risks (Grade B) (cardiovascular morbidity (transferable evidence, LoE 1), renal function and hepatic function (transferable evidence, LoE 3) or actual or recent gastroduodenal ulcer history (LoE 4)

Clinical practice

  • COX-2-selective inhibitors should be administered at the appropriate time to provide sufficient analgesia when the patient wakes
  • Rofecoxib has been withdrawn from the market, and marketing of valdecoxib has been suspended in most countries

Transferable evidence

  • One randomised trial in patients undergoing vaginal hysterectomy or breast surgery showed that rofecoxib was as effective as diclofenac in terms of postoperative analgesia, but was associated with less use of anti-emetics
  • Rofecoxib 50 mg and parecoxib 40 mg have an equipotent analgesic efficacy relative to traditional NSAIDs in postoperative pain after minor and major surgical procedures (
  • A systematic review to quantify the efficacy of single-dose oral valdecoxib and IV parecoxib demonstrated that both are effective treatments for acute postoperative pain, and show similar incidences of adverse effects
  • Randomised endoscopic trials in healthy elderly volunteers have shown that COX-2-selective inhibitors are associated with a lower incidence of upper gastrointestinal ulceration compared with conventional NSAIDs for short-term use (
  • Studies in healthy volunteers demonstrated that COX-2-selective inhibitors had no effect on platelet aggregation or bleeding time compared with placebo Greenberg et al 2000 Click here for more information
  • Clinical studies investigating the response to oral challenge with COX-2-selective inhibitors in patients with aspirin-induced asthma have demonstrated that COX-2-selective inhibitors do not have an effect on respiratory function (
  • A study to assess the safety of the COX-2-selective inhibitors parecoxib and valdecoxib following non-cardiac general surgery (including gastrointestinal, orthopaedic, gynaecological, urological, and thoracic surgeries) showed no difference in the incidence of cardiovascular thromboembolic events, renal dysfunction/failure, gastrointestinal ulcer complications, and surgical wound-healing complications, compared with placebo (n=1062) (
  • Two meta-analyses comparing pre-incisional and post-incisional conventional NSAIDs/COX-2-selective inhibitors have found no significant benefit of pre-incisional administration for reducing pain scores (
  • Two clinical trials showed that in patients who had undergone CABG surgery, COX-2-selective inhibitors (valdecoxib and parecoxib) were associated with a higher rate of serious cardiovascular thromboembolic events (including myocardial infarction) compared with placebo (
  • Hypersensitivity reactions and serious skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) can occur with all COX-2-selective inhibitors. Serious skin reactions have been reported in association with valdecoxib at a higher rate than with other COX-2-selective agents (
  • Conventional NSAIDs and COX-2-selective inhibitors have been associated with an increased risk of transient hepatotoxicity. Cases of acute hepatic failure have also been reported (with lumiracoxib; (
  • Short-term use of COX-2-selective inhibitors or conventional NSAIDs can increase the risk of transient renal impairment, especially in patients with existing renal dysfunction, and both types of agent have been associated with cases of acute renal failure in high-risk patients (
  • Chronic administration of COX-2-selective inhibitors and conventional NSAIDs may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication (

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Pre-operative parenteral glucocorticoids are recommended (Grade B), based on limited procedure-specific (LoE 1 and 2) and transferable evidence (LoE 1) for analgesic efficacy

Clinical practice

  • None cited

Transferable evidence

  • Dexamethasone significantly reduced pain scores compared with placebo following laparoscopic cholecystectomy (
  • Dexamethasone was shown to prevent postoperative nausea and vomiting after surgery in a systematic review
  • A single prophylactic dose of dexamethasone (4–8 mg) is effective for preventing PONV in surgery associated with high emetic effects (
  • Meta-analyses of randomised controlled trials showed that peri-operative methylprednisolone was not associated with a significant increase in adverse effects after cardiac, non-cardiac and trauma surgery
  • A randomised controlled trial in patients undergoing anorectal surgery demonstrated that pre-operative IV dexamethasone did not increase the incidence of adverse events or the rate of wound infection compared with placebo
  • A randomised controlled trial in patients undergoing anorectal surgery reported comparable pain scores with pre-operative IV dexamethasone versus placebo

Haemorrhoid surgery-specific evidence

  • VAS pain scores were significantly lower with betamethasone versus placebo at 2 h (p<0.04), but not at 0, 1, 3, and 4 h. Verbal pain scores when sitting were significantly lower with betamethasone compared with placebo at 5–24 h (p<0.04), but verbal pain scores at rest were not significantly different at any time point (i.e. at 0, 1, 2, 3, 4 or 5–24 h) (
  • Pain scores (assessed using a verbal categorical scale, where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) were lower with betamethasone compared with diclofenac, but no statistics were reported (
  • Significantly fewer patients required rescue analgesia (parenteral pethidine 50 mg) in a betamethasone group versus a diclofenac group (p<0.05) (
  • The incidence of postoperative nausea and vomiting was lower with betamethasone compared with placebo, although no statistics were reported (
  • A greater proportion of patients receiving betamethasone (75%) were discharged from hospital on the day of surgery compared with patients receiving diclofenac (0%), although no statistics were reported (
  • Time to eligibility for discharge and time to actual discharge from hospital were not significantly different between groups receiving either betamethasone or placebo (
  • Study details Aasboe 1998 Click here for more information

PROSPECT Recommendation

  • Ketamine cannot be recommended (Grade D, LoE 4) because there is no procedure-specific evidence and because the benefit:risk ratio is not sufficiently favourable for this ambulatory procedure, despite analgesic efficacy in other procedures (transferable evidence, LoE 1)
  • Dextromethorphan is not recommended (Grade D, LoE 4) based on inconclusive procedure-specific evidence and transferable evidence

Clinical practice

  • Administration of IM dextromethorphan is not widely used in clinical practice

Transferable evidence

  • Studies of ketamine in a variety of surgeries, including abdominal, gynaecological, orthopaedic, gastric, hepatic, and genitourinary surgery, showed a reduction in postoperative pain or opioid use when used as an adjunct to morphine (
  • Low-dose ketamine was associated with few and mild adverse effects, especially when administered in conjunction with general anaesthesia (
  • A systematic review found that dextromethorphan did not reduce postoperative pain scores with a clinically significant magnitude, and although significant decreases in supplemental opioid consumption were observed, these were of questionable clinical importance in most cases (
  • Two meta-analyses comparing pre-incisional and postincisional treatments found no significant analgesic benefit of pre-incisional administration of NMDA receptor antagonists (
  • Two systematic reviews of randomised controlled trials comparing magnesium with placebo demonstrated inconclusive results overall with regards to pain scores and supplemental analgesic use

Haemorrhoid surgery-specific evidence

  • Highest VAS pain scores were significantly lower with oral dextromethorphan 240 mg compared with placebo (p<0.001); there were no significant differences between oral dextromethorphan 120 mg and placebo groups (
  • Worst pain scores were significantly lower with IM dextromethorphan + CPM compared with CPM alone (p<0.001) (
  • In a group receiving IM dextromethorphan + CPM, the total pethidine consumption was significantly lower, compared with a group receiving CPM alone (p<0.001). The proportion of patients who required pethidine injection was significantly fewer with dextromethorphan + CPM versus CPM alone (p<0.005) (
  • Total pethidine consumption was significantly lower with oral dextromethorphan 240 mg compared with placebo (p<0.001); there were no significant differences between oral dextromethorphan 120 mg and placebo groups, and no significant differences in the proportion of patients who required pethidine injections between any of the three groups were observed (
  • The time to first pethidine injection was significantly longer with IM dextromethorphan + CPM compared with CPM alone (p=0.006) (
  • Patients receiving oral dextromethorphan 240 mg had a significantly longer time to first pethidine injection compared with patients receiving placebo (p<0.001); there were no significant differences between oral dextromethorphan 120 mg and placebo groups (
  • The incidence of pethidine-related side-effects (nausea, vomiting, dizziness and headache) was significantly lower with oral dextromethorphan 240 mg compared with placebo (p<0.05); the incidence was similar with oral dextromethorphan 120 mg and placebo (
  • The incidence of pethidine-related side-effects (such as nausea, vomiting, dizziness and headache) was similar with IM dextromethorphan + CPM and CPM alone (
  • The incidence of urinary retention was comparable between patients receiving IM dextromethorphan + CPM and those receiving CPM alone (
  • There was no significant difference in the incidence of postoperative bleeding in patients receiving IM dextromethorphan + CPM and those receiving CPM alone (
  • Study details Liu 2000 Click here for more information

PROSPECT Recommendations

  • Pre-incisional administration of strong opioids, including transdermal fentanyl, is not recommended (Grade D, LoE 4) due to lack of procedure-specific and transferable evidence

Clinical practice

  • The use of a transdermal patch is not feasible, as haemorrhoid surgery is an outpatient procedure and it is not practical to administer the patch 6 h prior to surgery
  • The use of transdermal fentanyl patches is contraindicated in settings of acute and postoperative pain, in particular in opioid-naiive patients, due to the risk of severe respiratory depression; fatal outcomes have been reported
  • Strong opioids cause constipation, which may hinder recovery
  • Non-opioid analgesics should be used instead of opioids to avoid the risk of constipation

Transferable evidence

  • Strong opioids are effective for reducing high- and moderate-intensity postoperative pain (
  • Pethidine induced significantly higher sedation and respiratory depression compared with tramadol (both 100 mg intravenously) in patients undergoing orthopaedic surgery (n=48) (
  • Strong opioids are associated with adverse effects, including nausea, vomiting, sedation, confusion, paralytic ileus and urinary retention (

Haemorrhoid surgery-specific evidence

  • VAS pain scores were significantly lower with the fentanyl patch compared with the placebo patch at 12, 16 and 24 h (all p<0.05), but not at 6, 30, 36, 48 and 72 h (
  • Consumption of rescue analgesia was significantly lower with the fentanyl patch compared with the placebo patch (IM pethidine, and propoxyphene tablets from 24–72 h; both p<0.05) (
  •  No patients reported pruritus with the fentanyl patch and only one patient reported pruritus with the placebo patch (
  • The incidence of postoperative nausea and vomiting was similar with the fentanyl patch and the placebo patch (
  • The number of patients with urinary retention was similar with the fentanyl patch and the placebo patch (
  • Study details Kilbride 1994 Click here for more information

PROSPECT Recommendations

  • It is recommended (Grade B) that paracetamol should be administered at the appropriate time to provide sufficient analgesia in the early recovery period, based on transferable evidence showing efficacy for treating pain of moderate intensity (LoE 1)

Clinical practice

  • It is considered that paracetamol is ineffective as a single therapy for treatment of high-intensity pain (VAS >/=50 mm)

Transferable evidence

  • Paracetamol is an effective analgesic for the treatment of postoperative pain of moderate intensity (
  • There is evidence that concurrent use of paracetamol and conventional NSAIDs improves pain relief compared with paracetamol alone, but there is no evidence for a superior analgesic effect of the combination compared with conventional NSAIDs alone (

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Laxatives are recommended (Grade A) in the days prior to surgery, as an adjunct to analgesic therapy, based on procedure-specific evidence (LoE 1 and 2)

Clinical Practice

  • Stool softeners are an alternative to laxatives in clinical practice

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Two studies out of two demonstrated that laxatives caused a significant reduction in pain scores on defecation compared with placebo/control London 1987 Click here for more information
  • There was a significant reduction in VAS pain scores on day 10 with Plantago ovata compared with control (p<0.01), but not on day 20 (
  • In one study, oral paracetamol requirements after defecation were significantly lower with lactulose compared with placebo (p<0.01), although IM papaveretum consumption was not significantly different between groups, and analgesic requirements before defecation (papaveretum and paracetamol) were similar (
  • Two studies out of two demonstrated a shorter length of hospital stay with laxatives compared with placebo/control (
  • The tenesmus rate in patients in a Plantago ovata group was significantly lower than in patients in a control group (p<0.01) (
  • The time to first bowel action was significantly shorter in patients receiving lactulose compared with patients receiving placebo (p=0.01), although the number of bowel actions in the first week was not significantly different between groups (p=0.05) (
  • There were no significant differences between groups treated with lactulose and placebo in VAS or VRS pain scores in the 24 h preceding defecation on POD 1–3 (
  • Study details London 1987 Click here for more information

PROSPECT Recommendations

  • Topical EMLA is not recommended (Grade B) based on limited procedure-specific evidence (LoE 1) showing a lack of analgesic benefit

Clinical Practice

  • None cited

Tranferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Pain scores were not significantly different between groups receiving EMLA or placebo cream (
  • Patient satisfaction scores with the procedure as a whole were similar with EMLA cream and placebo cream (
  • Study details Roxas 2003 Click here for more information

PROSPECT Recommendations

  • When used as an adjunct to anaesthesia, perianal LA infiltration is recommended for intra- and postoperative analgesia (Grade A), based on procedure-specific evidence for analgesic efficacy (LoE 1)

Clinical Practice

  • Haemorrhoid surgery is a short procedure, and therefore the effects of LA infiltration may be most beneficial when administered pre-operatively
  • Long-acting local anaesthetics are preferred to short-acting local anaesthetics for analgesia by local injection
  • Epinephrine is commonly used for LA infiltration, as it is often combined in a preparation with lidocaine and some other LAs

Transferable Evidence

  • There is evidence from a variety of surgical procedures that the efficacy of local anaesthetics for postoperative analgesia is similar following pre-operative or post-incisional administration
  • A systematic review of local anaesthesia infiltration showed inconclusive evidence of analgesic efficacy in hysterectomy, open cholecystectomy and a variety of other surgical procedures, but consistent and clinically relevant pain relief in herniorraphy (Moiniche 1998). Also see the Herniorraphy review at www.postoppain.org: Pre-operative or Intra-operative section, Local Anaesthetic Techniques, Inguinal nerve block/field block/infiltration and instillation

Haemorrhoid surgery-specific evidence

  • Two studies out of two demonstrated lower VAS pain scores at rest with LA infiltration compared with placebo Morisaki 1996 Click here for more information
  • One study out of one reported significantly lower VAS pain scores during coughing with LA infiltration compared with placebo on POD3 (p<0.05), but not on POD1–2 (
  • One study out of two demonstrated lower VAS pain scores on first bowel movement with LA (lidocaine) infiltration compared with placebo (p<0.05;
  • In two studies out of two, rescue analgesic requirements were lower with LA infiltration compared with placebo Morisaki 1996 Click here for more information
  • In one study out of one, the time to first analgesic request was significantly longer with LA infiltration compared with placebo (p=0.02;
  • In one study out of one, the time to first passage of faeces was similar with LA infiltration and placebo (
  • In one study out of one, micturition difficulties occurred with a similar frequency in patients receiving LA infiltration or placebo, and there was no reported incidence of nausea or vomiting in either group (
  • Study details Morisaki 1996 Click here for more information

PROSPECT Recommendations

  • Nerve blocks (perineal, pudendal, ischiorectal fossa blocks), as adjuncts to anaesthesia, are recommended for intra- and postoperative analgesia (Grade A) based on procedure-specific evidence for analgesic efficacy (LoE 1)
  • No recommendation can be made regarding the choice of nerve block at this time due to a lack of procedure-specific evidence directly comparing different blocks
  • Perianal LA infiltration may be preferable to nerve blocks because of the simplicity of administration (Grade D, LoE 4) but there is a lack of procedure-specific evidence comparing these techniques

Clinical Practice

  • Perineal and pudendal nerve blocks require clinical experience, and their risks and benefits have not yet been evaluated in comparison with perianal LA infiltration

Transferable Evidence

  • A randomised study reported similar pain scores, satisfaction scores and incidences of urinary retention and bleeding with local perianal nerve block and with regional anaesthesia (spinal or caudal), in patients undergoing a variety of anorectal procedures (including haemorrhoidectomy, fistulectomy, lateral sphincterotomy, excision of anal polyps, and drainage of abscesses)

Haemorrhoid surgery-specific evidence

  • VAS pain scores were significantly lower with posterior perineal block compared with no injection at 1, 2, 4, 8 and 24 h (all p=0.001), but not at 12 h (
  • Consumption of IV morphine in the PACU and 24 h morphine consumption were significantly lower with posterior perineal block compared with no injection (both p<0.001) (
  • Patients receiving posterior perineal block had a shorter duration of PACU stay compared with patients receiving no injection (p<0.001), although duration of hospital stay was not significantly different between groups (
  • Patient satisfaction scores were significantly higher with posterior perineal block compared with no injection (p<0.05) (
  • Two out of two studies demonstrated significantly lower VAS pain scores with GA plus pudendal nerve block compared with GA plus placebo nerve blocks or GA alone Naja 2005 Click here for more information
  • Two out of two studies demonstrated that patients receiving GA plus pudendal nerve block had significantly fewer days of pain during walking (p=0.001) and while sitting (p=0.0001) compared with patients receiving GA plus placebo nerve blocks or GA alone (
  • Two out of two studies showed that significantly fewer patients required opioid-containing analgesics during the first 6 days after surgery with GA plus pudendal nerve block compared with GA plus placebo nerve blocks and/or GA alone (IM pethidine 1 mg/kg if VAS >/=40, oral dextropropoxifen 30 mg + paracetamol 400 mg if VAS<40) (
  • One study out of two showed that the incidence of urinary retention was significantly lower with GA plus pudendal nerve block compared with GA alone (p=0.004), although the incidence of urinary incontinence was similar between groups ( Naja 2005 Click here for more information
  • Two studies out of two reported that the length of hospital stay was significantly shorter with GA plus pudendal nerve block compared with GA plus placebo nerve blocks and/or GA alone (
  • Two out of two studies showed that patients receiving GA plus pudendal nerve block resumed normal activities in a significantly shorter period of time compared with GA plus placebo nerve blocks and/or GA alone (
  • Two studies out of two demonstrated that patient satisfaction was significantly higher with GA plus pudendal nerve block compared with GA plus placebo nerve blocks and/or GA alone (
  • VAS pain scores were significantly lower with ischiorectal fossa block compared with no block at 30 min (p=0.0313), 4 h (p=0.0144) and 24 h (p=0.0015), but not at 2 h (
  • Patients treated with either posterior perineal block or no injection had a similar time to first bowel action (
  • There were no incidences of nausea or vomiting, fecaloma or urinary retention in patients receiving either posterior perineal block or no injection (
  • Two studies out of two reported that the incidences of nausea and vomiting were similar with GA plus pudendal nerve block compared with GA plus placebo nerve blocks and/or GA alone (
  • There were no significant differences in parenteral fentanyl, oral oxycodone, or 'simple analgesia' (dextropropoxyphene + paracetamol, or paracetamol alone) requirements, in patients treated with either ischiorectal fossa block or no block
  • The length of hospital stay was similar with ischiorectal fossa block and no block (
  • Posterior perineal injection versus no treatment (GA in both groups)
  • Study details Brunat 2003 Click here for more information
  • Pudendal nerve block versus placebo nerve block/no treatment (GA in all groups)
  • Study details Naja 2005 Click here for more information
  • Ischiorectal fossa block versus no block (perianal infiltration and GA in both groups)
  • Study details Luck 2000 Click here for more information

PROSPECT Recommendations

  • Caudal LA or opioid reduces postoperative pain (procedure-specific evidence, LoE 1 and 2), but is not recommended (Grade D, LoE 4), due to an insufficient risk:benefit ratio

Clinical Practice

  • The risk of side-effects associated with caudal analgesia may outweigh the analgesic benefits in routine haemorrhoid surgery

Transferable evidence

  • In a randomised study of elective perianal surgery, patients who received either a caudal injection of bupivacaine or diamorphine had better analgesia than patients receiving a control injection. Side-effects were less frequent with caudal diamorphine compared with caudal bupivacaine or control; 41% of patients treated with caudal bupivacaine experienced urinary retention and one patient required temporary catheterisation

Haemorrhoid surgery-specific evidence

  • On POD1, pain scores were significantly lower with caudal infiltration of bupivacaine versus lidocaine (p<0.05), morphine versus lidocaine (p<0.05), and morphine-lidocaine versus lidocaine (p<0.01). On POD2, pain scores were significantly lower with caudal infiltration of bupivacaine versus lidocaine (p<0.01), morphine versus lidocaine (p<0.05), and no injection versus lidocaine (p<0.01). There were no significant differences in pain scores between any other groups (
  • The proportion of patients requiring postoperative opiates was significantly fewer with the group receiving caudal infiltration of morphine and the group receiving caudal infiltration of morphine-lidocaine compared with the group receiving caudal injection of lidocaine (both p<0.05); there were no significant differences between any other groups (
  • Patients in a morphine caudal infiltration group and in a bupivacaine caudal infiltration group had a significantly longer duration of analgesia compared with patients receiving no injection (p<0.01), or patients in a lidocaine caudal infiltration group (p<0.01). Patients receiving caudal infiltration of morphine-lidocaine had a significantly longer duration of analgesia compared with those receiving no injection (p<0.05). There were no significant differences between any other groups (
  • The incidence of gastric upsets was significantly lower with caudal ketorolac versus IV ketorolac (p=0.0444) (
  • The incidence of bleeding disorders was significantly lower with caudal ketorolac compared with IV ketorolac (p=0.0098) (
  • VAS pain scores were significantly lower with caudal injection compared with local infiltration on awakening, at 3 h (both p<0.05), at 6 h (p<0.01) and at first bowel action (p<0.05), but not at 12, 24 and 48 h or on pack removal (
  • The number of patients reporting no pain was significantly fewer with caudal injection compared with local infiltration on awakening (p<0.05) and at 3 and 6 h (both p<0.01), but not at 12, 24 and 48 h, on pack removal, or at first bowel action (
  • There were no significant differences in nausea or micturition scores between groups receiving a caudal injection of bupivacaine, lidocaine, morphine, morphine-lidocaine, or no injection (
  • The requirement for urinary catheterisation was higher with groups receiving a caudal injection compared with those receiving no injection, but no statistics were reported (
  • There were no significant differences between groups receiving caudal or IV ketorolac in VAS pain scores when sitting or supine at any time-point assessed (i.e. at 1, 1.5, 2, 2.5, 3, 4, 5, 6, 10 and 24 h) (
  • There were no significant differences between groups receiving caudal or IV ketorolac in the proportion of patients requiring IV pethidine injection, the number of pethidine doses requested, or the time to first request for rescue analgesia (
  • There were no significant differences between patients receiving caudal injection or local infiltration in number of patients requiring supplementary analgesia (IM papaveretum or oral coproxamol), the mean number of requests for analgesia, or the time to first analgesia (
  • The time to first bowel action was similar with caudal injection and local infiltration (
  • There was no significant difference in the length of hospital stay with caudal injection and local infiltration (
  • The postoperative complication rate (including urinary retention, haemorrhage and infection) was similar with caudal injection and local infiltration (
  • Caudal infiltration with or without opioid or LA, versus placebo (GA in all groups)
  • Study details Pybus 1983 Click here for more information
  • Caudal NSAID versus IV NSAID
  • Study details Yosry 2004 Click here for more information
  • Caudal LA injection versus local wound infiltration (GA in both groups)
  • Study details Pryn 1989 Click here for more information

PROSPECT Recommendations

  • No recommendation can be made regarding the choice of anaesthetic technique (local anaesthesia versus spinal anaesthesia [appropriate ‘short-duration’ spinal] versus general anaesthesia), due to limited procedure-specific evidence
  • Addition of adjuncts to the spinal LA solution is not recommended (Grade D, LoE 4) due to potential side-effects

Clinical Practice

  • The type of spinal anaesthesia used should be appropriate for ambulatory procedures
  • As haemorrhoid surgery is performed on an outpatient basis, there may be safety concerns regarding administration of spinal opioids, such as the potential for delayed respiratory depression
  • Epinephrine is commonly used for LA infiltration, as it is often combined in a preparation with lidocaine and some other LAs
  • Perineal and pudendal nerve blocks require clinical experience, and their risks and benefits have not yet been evaluated in comparison with perianal LA infiltration
  • The questions around neurotoxicity of midazolam are not yet resolved and it should not be used spinally or epidurally in view of uncertain safety

Transferable Evidence

  • A randomised study reported similar pain scores, satisfaction scores and incidences of urinary retention and bleeding with regional anaesthesia (spinal or caudal) and with local perianal nerve block, in patients undergoing a variety of anorectal procedures (including haemorrhoidectomy, fistulectomy, lateral sphincterotomy, excision of anal polyps, and drainage of abscesses)
  • Spinal administration of strong opioids is associated with side-effects including pruritus, PONV, urinary retention, and respiratory depression (

Haemorrhoid surgery-specific evidence

  • The maximal VAS pain score was significantly lower with pudendal nerve block compared with spinal anaesthesia (p<0.001;
  • The number of patients requiring analgesics and the total number of injections administered were significantly lower with pudendal nerve block compared with spinal anaesthesia (both p<0.001;
  • The time to first experiencing postoperative pain was significantly longer with pudendal nerve block compared with spinal anaesthesia (p<0.001;
  • A significantly lower number of patients required urinary catheterisation with pudendal nerve block compared with spinal anaesthesia (p<0.001;
  • Pain scores (assessed on a scale from 0–3) were significantly lower with spinal bupivacaine + morphine compared with spinal bupivacaine alone at 4 (p<0.05) and 6 h (p<0.001), but not at 2, 8, 10 or 12 h (
  • Fewer patients receiving spinal bupivacaine + morphine requested supplementary morphine (10 mg IM) compared with patients receiving spinal bupivacaine alone, but no statistics were reported (
  • The number of administrations of oral analgesic tablets requested in 24 h was significantly fewer with spinal bupivacaine + 1 mg midazolam and spinal bupivacaine + 2 mg midazolam compared with spinal bupivacaine + saline (both p<0.01) (two paracetamol 300 mg + codeine 30 mg tablets taken every 4 h as needed) (
  • The time to the first administration of pain medication was significantly longer with spinal bupivacaine + 1 mg midazolam and spinal bupivacaine + 2 mg midazolam compared with spinal bupivacaine + saline (both p<0.01), and significantly longer with spinal bupivacaine + 2 mg midazolam compared with spinal bupivacaine + 1 mg midazolam (p<0.05;
  • There were no significant differences in pain scores after infiltration of local anaesthetic or immediately after the operation in patients undergoing the Nivatvongs technique versus conventional LA infiltration (
  • The incidence of persistent pain or discomfort was similar with the Nivatvongs technique and conventional LA infiltration (
  • The incidence of fecal impaction was similar with the Nivatvongs technique and conventional LA infiltration (
  • Patient satisfaction with the anaesthesia and with the whole procedure were similar with the Nivatvongs technique and conventional LA infiltration (
  • VAS pain scores at 6 and 24 h were not significantly different between patients undergoing local anaesthetic infiltration or spinal anaesthesia (
  • The number of days that patients required analgesics (paracetamol 1 g and codeine 16 mg every 6 h) was similar with local anaesthetic infiltration and spinal anaesthesia (
  • The incidence of urinary retention was not significantly different with local anaesthetic infiltration (n=0) and spinal anaesthesia (n=1) (
  • The incidence of bleeding was not significantly different with local anaesthetic infiltration (n=1) and spinal anaesthesia (n=2) (
  • The incidence of urinary retention was similar with spinal bupivacaine + morphine and spinal bupivacaine alone (
  • VAS pain scores at the time of the first administration of pain medication were not significantly different between groups treated with spinal bupivacaine + 1 mg midazolam, spinal bupivacaine + 2 mg midazolam, and spinal bupivacaine + saline (
  • The time to first self-voiding was similar with spinal bupivacaine + 1 mg midazolam, spinal bupivacaine + 2 mg midazolam, and spinal bupivacaine + saline (
  • The incidences of urinary retention, sedation and nausea/vomiting were similar with spinal bupivacaine + 1 mg midazolam, spinal bupivacaine + 2 mg midazolam, and spinal bupivacaine + saline (
  • Intra-anal injection (Nivatvongs technique) versus conventional local anaesthetic infiltration
  • Study details Roxas 2006 Click here for more information
  • Local anaesthetic infiltration versus spinal anaesthesia
  • Study details Ong 2005 Click here for more information
  • Pudendal nerve block versus spinal anaesthesia
  • Study details Kim 2005 Click here for more information
  • Spinal LA with or without morphine
  • Study details Amanor-Boadu 1992 Click here for more information
  • Spinal LA with or without midazolam
  • Study details Kim 2001 Click here for more information

Intra-operative analgesia

To ensure an adequate analgesic effect in the immediate postoperative period, it may be necessary to administer analgesic medication prior to the postoperative period, e.g. conventional NSAIDs, COX-2-selective inhibitors, paracetamol

PROSPECT Recommendations

  • Injection of botulinum toxin is not recommended (Grade D, LoE 4), due to inconsistent procedure-specific evidence for analgesic benefit in the postoperative period

Clinical Practice

  • The injection of botulinum toxin for pain after haemorrhoid surgery is not performed routinely in clinical practice

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Two out of two studies demonstrated a decrease in pain scores with Botox injection compared with placebo injection Davies 2003 Click here for more information
  • One study out of two showed a decrease in rescue analgesic consumption with Botox compared with placebo Patti 2005 Click here for more information
  • In one study out of one, the time to complete healing of wounds was significantly shorter with Botox compared with placebo (p<0.001;
  • In one study out of one, the time to return to work was significantly shorter in a Botox group versus a placebo group (p<0.05;
  • The time to first defecation was similar in groups receiving either Botox or placebo in two out of two studies (
  • In one study out of one, the incidence of anal incontinence was similar with Botox and placebo (
  • In one study out of one, the incidence of urinary retention was similar with Botox and placebo (
  • In two studies out of two, there was no significant difference in the length of hospital stay with Botox and placebo (
  • Study details Davies 2003 Click here for more information

PROSPECT Recommendations

  • Stapled haemorrhoid surgery is recommended (Grade A) based on reduced pain compared with other surgical techniques (procedure-specific evidence, LoE 1)
  • The choice of haemorrhoid operative techniques may depend on factors other than postoperative pain alone

Clinical Practice

  • The choice of haemorrhoid operative technique may depend on factors other than postoperative pain alone

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Closed versus open haemorrhoidectomy
  • Closed versus closed haemorrhoidectomy

PROSPECT Recommendations

  • No recommendation can be made regarding the choice of haemorrhoid dissection technique based on their effect on postoperative pain alone

Clinical Practice

  • None cited

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Summary of studies Click here for more information
  • Diathermy dissection versus conventional scissors dissection
  • Harmonic Scalpel™ dissection versus conventional scissors dissection
  • Dissection with radiofrequency bistoury versus conventional scissors dissection
  • Diathermy dissection versus Harmonic Scalpel™ dissection
  • LigaSure™ diathermy dissection versus conventional diathermy dissection
  • Cold scalpel dissection versus laser dissection

PROSPECT Recommendations

  • Lateral sphincterotomy as an adjunct to haemorrhoid surgery is not recommended for analgesia (Grade D, LoE 4) due to limited and inconsistent procedure-specific evidence
  • The use of an anal dilator as an adjunct to haemorrhoid surgery is not recommended for analgesia (Grade D, LoE 4) based on limited procedure-specific evidence

Clinical Practice

  • None cited

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Open haemorrhoidectomy, with or without lateral sphincterotomy
  • Closed haemorrhoidectomy, with or without lateral sphincterotomy
  • Diathermy haemorrhoidectomy, with or without lateral sphincterotomy
  • Anal dilator versus no treatment

Postoperative studies 

Data in this section are available from studies that assessed postoperative analgesia versus postoperative placebo, as well as those that assessed postoperative analgesia versus the same analgesia given pre-operatively or intra-operatively.

PROSPECT Recommendations

  • Postoperative gabapentinoids cannot be recommended (Grade D, LoE 4) because there is no procedure-specific evidence and because the benefit:risk ratio is not sufficiently favourable for this ambulatory procedure, despite analgesic efficacy in other procedures (transferable evidence, LoE 1)

Clinical Practice

  • None cited

Transferable Evidence

  • Three systematic reviews and a meta-analysis evaluated the use of gabapentinoids for postoperative analgesia and demonstrated significant reductions in postoperative pain and supplementary analgesic requirements compared with inactive controls (
  • Two systematic reviews (
  • Two systematic reviews (

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Postoperative systemic conventional NSAIDs are recommended (Grade B) based on transferable evidence showing analgesic efficacy (LoE 1)
  • There is not enough evidence at this time to recommend the use of one NSAID over another
  • The use of conventional NSAIDs should depend upon assessment of individual patient risks (Grade B), including bleeding complications, actual or recent gastroduodenal ulcer history (transferable evidence, LoE 1), cardiovascular morbidity (LoE 4), aspirin-sensitive asthma, renal function and hepatic function (transferable evidence, LoE 3)

Clinical Practice

  • Conventional NSAIDs should be administered at the appropriate time to provide sufficient analgesia when the patient wakes

Transferable Evidence

  • Conventional NSAIDs have proven analgesic efficacy in a variety of surgical procedures (
  • One randomized study in patients undergoing colorectal resection demonstrated that patients receiving IV PCA morphine plus ketorolac required significantly less rescue analgesic than patients receiving IV PCA morphine alone (with comparable pain scores), although recovery of bowel function was not significantly different between the two groups
  • A meta-analysis of randomised controlled trials that was performed to evaluate the risk of morphine-related adverse effects in patients treated with NSAIDs demonstrated that NSAIDs decreased the incidence of nausea, vomiting and sedation, but not pruritus, urinary retention or respiratory depression (
  • Randomised endoscopic trials in healthy elderly volunteers have shown that COX-2-selective inhibitors are associated with a lower incidence of upper gastrointestinal ulceration compared with conventional NSAIDs for short-term use (
  • Randomised trials in healthy volunteers showed that conventional NSAIDs (ketorolac, naproxen or diclofenac) reduced the platelet aggregation response compared with placebo; ketorolac and naproxen also prolonged bleeding time compared with placebo (
  • Meta-analyses of randomised controlled trials showed that peri-operative conventional NSAIDs increased the risk of postoperative bleeding requiring treatment and/or the risk of re-operation for haemostasis after tonsillectomy compared with controls (
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction
  • A randomised controlled trial showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) were associated with a similar incidence of surgical site bleeding after elective surgery
  • Aspirin and conventional NSAIDs can induce asthma attacks in patients with aspirin-exacerbated respiratory disease (
  • Conventional NSAIDs and COX-2-selective inhibitors have been associated with an increased risk of transient hepatotoxicity. Cases of acute hepatic failure have also been reported (with lumiracoxib;
  • Short-term use of conventional NSAIDs or COX-2-selective inhibitors can increase the risk of transient renal impairment, especially in patients with existing renal dysfunction, and both types of agent have been associated with cases of acute renal failure in high-risk patients (
  • Chronic administration of conventional NSAIDs and COX-2-selective inhibitors may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication (

Haemorrhoid surgery-specific evidence

  • The time to first bowel movement was significantly shorter in a group receiving diflunisal compared with a group receiving oral paracetamol + weak opioid (p<0.05;
  • Pain scores (rated on a scale from 0–3) were not significantly different in groups receiving either diflunisal or oral paracetamol + weak opioid, at any time point assessed (i.e. at 4 h intervals from 16–72 h) (
  • There were no significant differences between groups treated with either nimesulide or naproxen in VAS pain scores at any time point recorded (i.e. twice per day on POD 1, 2, 3, 4, 11, and 20) (
  • Pain scores (assessed using a verbal categorical scale, where 0=no pain, 1=mild pain, 2=moderate pain, and 3=severe pain) were higher with diclofenac compared with betamethasone, but no statistics were reported (
  • The proportion of patients requiring additional IM pethidine injections as rescue analgesia was similar with diflunisal and oral paracetamol + weak opioid (
  • A significantly higher proportion of patients required rescue analgesia (parenteral pethidine 50 mg) in a diclofenac group versus a betamethasone group (p<0.05;
  • More patients receiving betamethasone (75%) were discharged from hospital on the day of surgery compared with patients receiving diclofenac (0%), although no statistics were reported (
  • Global efficacy as assessed by patients and doctors was similar with nimesulide and naproxen (
  • Length of hospital stay was comparable with diflunisal and oral paracetamol + weak opioid (
  • Study details Madsen 1987 Click here for more information

PROSPECT Recommendations

  • Postoperative COX-2-selective inhibitors are recommended (Grade B) based on transferable evidence showing analgesic efficacy (LoE 1)
  • It is recommended that the use of COX-2-selective inhibitors should depend upon assessment of individual patient risks (Grade B) (cardiovascular morbidity (transferable evidence, LoE 1), renal function and hepatic function (transferable evidence, LoE 3) or actual or recent gastroduodenal ulcer history (LoE 4)

Clinical Practice

  • COX-2-selective inhibitors should be administered at the appropriate time to provide sufficient analgesia when the patient wakes
  • Rofecoxib has been withdrawn from the market, and marketing of valdecoxib has been suspended in most countries

Transferable Evidence

  • Rofecoxib 50 mg and parecoxib 40 mg have an equipotent analgesic efficacy relative to traditional NSAIDs in postoperative pain after minor and major surgical procedures (
  • A systematic review to quantify the efficacy of single-dose oral valdecoxib and IV parecoxib demonstrated that both are effective treatments for acute postoperative pain, and show similar incidences of adverse effects
  • Randomised endoscopic trials in healthy elderly volunteers have shown that COX-2-selective inhibitors are associated with a lower incidence of upper gastrointestinal ulceration compared with conventional NSAIDs for short-term use (
  • Studies in healthy volunteers demonstrated that COX-2-selective inhibitors had no effect on platelet aggregation or bleeding time compared with placebo Greenberg et al 2000 Click here for more information
  • Clinical studies investigating the response to oral challenge with COX-2-selective inhibitors in patients with aspirin-induced asthma have demonstrated that COX-2-selective inhibitors do not have an effect on respiratory function (
  • A study to assess the safety of the COX-2-selective inhibitors parecoxib and valdecoxib following non-cardiac general surgery (including gastrointestinal, orthopaedic, gynaecological, urological, and thoracic surgeries) showed no difference in the incidence of cardiovascular thromboembolic events, renal dysfunction/failure, gastrointestinal ulcer complications, and surgical wound-healing complications, compared with placebo (n=1062) (
  • Two clinical trials showed that in patients who had undergone CABG surgery, COX-2-selective inhibitors (valdecoxib and parecoxib) were associated with a higher rate of serious cardiovascular thromboembolic events (including myocardial infarction) compared with placebo (
  • Hypersensitivity reactions and serious skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme) can occur with all COX-2-selective inhibitors. Serious skin reactions have been reported in association with valdecoxib at a higher rate than with other COX-2-selective agents (
  • Conventional NSAIDs and COX-2-selective inhibitors have been associated with an increased risk of transient hepatotoxicity. Cases of acute hepatic failure have also been reported (with lumiracoxib;
  • Short-term use of COX-2-selective inhibitors or conventional NSAIDs can increase the risk of transient renal impairment, especially in patients with existing renal dysfunction, and both types of agent have been associated with cases of acute renal failure in high-risk patients (
  • Chronic administration of COX-2-selective inhibitors and conventional NSAIDs may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication (

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Ketamine cannot be recommended (Grade D, LoE 4) because there is no procedure-specific evidence at this time and because the benefit:risk ratio is not sufficiently favourable for this ambulatory procedure, despite analgesic efficacy in other procedures (transferable evidence, LoE 1)
  • Dextromethorphan is not recommended (Grade D, LoE 4) based on inconclusive procedure-specific and transferable evidence

Clinical Practice

  • Administration of IM dextromethorphan is not widely used in clinical practice

Transferable Evidence

  • Studies of ketamine in a variety of surgeries, including abdominal, gynaecological, orthopaedic, gastric, hepatic, and genitourinary surgery, showed a reduction in postoperative pain or opioid use when used as an adjunct to morphine (
  • Low-dose ketamine was associated with few and mild adverse effects, especially when administered in conjunction with general anaesthesia (
  • A systematic review found that dextromethorphan did not reduce postoperative pain scores with a clinically significant magnitude, and although significant decreases in supplemental opioid consumption were observed, these were of questionable clinical importance in most cases (
  • Two meta-analyses comparing pre-incisional and postincisional treatments found no significant analgesic benefit of pre-incisional administration of NMDA receptor antagonists (
  • Two systematic reviews of randomised controlled trials comparing magnesium with placebo demonstrated inconclusive results overall with regards to pain scores and supplemental analgesic use

Haemorrhoid surgery-specific evidence

  • In a group receiving IM dextromethorphan + CPM, the total pethidine consumption was significantly lower compared with a group receiving CPM alone (p<0.001). The proportion of patients who required pethidine injection was significantly fewer with IM dextromethorphan + CPM versus CPM alone (p<0.005;
  • The time to first pethidine injection was significantly longer with IM dextromethorphan + CPM compared with CPM alone (p=0.006;
  • The incidence of pethidine-related side-effects (such as nausea, vomiting, dizziness and headache) was significantly lower with IM dextromethorphan + CPM compared with CPM alone (p<0.025;
  • Worst pain scores in patients requesting pethidine were not significantly different with IM dextromethorphan + CPM compared with CPM alone (
  • Study details Chang 1999 Click here for more information

PROSPECT Recommendations

  • Strong opioids are recommended for moderate-to-high intensity postoperative pain (VAS>/= 30 mm) (Grade B), to supplement oral paracetamol and conventional NSAIDs/COX-2-selective inhibitors, based on transferable evidence for analgesic efficacy (LoE 1)

Clinical Practice

  • Strong opioids cause constipation, which may hinder recovery
  • Where possible, non-opioid analgesics should be used instead of opioids to avoid the risk of constipation

Transferable Evidence

  • Strong opioids are effective for reducing high- and moderate-intensity postoperative pain (
  • A systematic review comparing intravenous PCA opioids with intravenous, intramuscular or subcutaneous opioids by injection showed that PCA opioids were associated with greater pain relief, reduced supplemental analgesic requirements (analysis of eleven studies, total n=691), and more patients preferred PCA opioids (analysis of four trials, total n=352) compared with traditional opioid analgesia (
  • A quantitative systematic review showed that opioid by PCA provided better pain control and greater patient satisfaction than conventional opioid parenteral analgesia in a variety of surgical procedures (37/56 trials used IM analgesia in the control group) (
  • A meta-analysis of randomised controlled trials that was performed to evaluate the risk of morphine-related adverse effects in patients treated with NSAIDs demonstrated that combination of morphine plus NSAIDs decreased the incidence of nausea, vomiting and sedation, but not pruritus, urinary retention or respiratory depression, compared with morphine alone (
  • A systematic review showed that patients using PCA consumed a greater quantity of opioids than those treated using conventional opioid parenteral analgesia, and had a higher incidence of pruritus, but a similar incidence of other side-effects, in a variety of surgical procedures. There was no difference between groups in the length of hospital stay (
  • Pethidine induced significantly higher sedation and respiratory depression compared with tramadol (both 100 mg intravenously) (n=48;
  • Strong opioids are associated with adverse effects, including nausea, vomiting, sedation, confusion, paralytic ileus and urinary retention (
  • One study comparing PCA with conventional pain therapy (CPT; IV piritramide or oral/IM tramadol) demonstrated an increased consumption of postoperative analgesic in the PCA group compared with the CPT group (p<0.01), although the PCA group reported a significantly greater satisfaction with pain therapy compared with the CPT group (p<0.01; n=42 patients)

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Weak opioids are recommended for low-to-moderate intensity postoperative pain (VAS<50 mm) (Grade B), to supplement oral paracetamol and conventional NSAIDs/COX-2-selective inhibitors, based on transferable evidence for analgesic efficacy (LoE 1)

Clinical Practice

  • Weak opioids cause constipation, which may hinder recovery
  • Non-opioid analgesics should be used instead of opioids to avoid the risk of constipation
  • Tramadol causes less constipation than conventional opioids

Transferable Evidence

  • Tramadol was more effective than placebo for pain relief in a meta-analysis of post-surgical patients
  • The combination of tramadol and paracetamol enhances analgesic efficacy compared with either agent alone
  • A systematic review found that the combination of dextropropoxyphene 65 mg with paracetamol 650 mg showed similar efficacy to tramadol 100 mg
  • A systematic review found that the combination of codeine with paracetamol provided additional pain relief compared with paracetamol alone
  • A meta-analysis of randomised controlled trials found that the combination of codeine with ibuprofen caused an enhanced analgesic effect compared with ibuprofen alone, although the incidence of adverse effects was increased
  • Two studies found that codeine 30 mg + paracetamol 300 mg was associated with a higher incidence of constipation and vomiting than tramadol 37.5 mg + paracetamol 325 mg following arthroscopy
  • Adverse effects associated with tramadol include headache, nausea, vomiting, dizziness, and somnolence. A meta-analysis of individual patient data from randomised controlled trials found a dose-response of adverse effects with tramadol; postsurgical patients had fewer side-effects than dental patients
  • A systematic review found that the combination of codeine with paracetamol was associated with an increase in drowsiness and dizziness compared with paracetamol alone
  • A systematic review found an increased incidence of central nervous system adverse effects with paracetamol 650 mg plus dextropropoxyphene 65 mg compared with placebo, but the incidence of other adverse effects was reduced compared with tramadol 100 mg

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Postoperative paracetamol is recommended (Grade B), based on transferable evidence (LoE 1) showing efficacy for low-moderate pain (VAS <50 mm)
  • Paracetamol alone is not recommended for high-intensity pain (VAS >/=50 mm) (Grade B), based on transferable evidence (LoE 1) showing a lack of analgesic efficacy

Clinical Practice

  • It is considered that paracetamol is ineffective as a single therapy for treatment of high-intensity pain (VAS>50 mm)

Transferable Evidence

  • Paracetamol is an effective analgesic for the treatment of postoperative pain of moderate intensity (
  • There is evidence that concurrent use of paracetamol and conventional NSAIDs improves pain relief compared with paracetamol alone, but there is no evidence for a superior analgesic effect of the combination compared with conventional NSAIDs alone

Haemorrhoid surgery-specific evidence

  • None cited

PROSPECT Recommendations

  • Injection of botulinum toxin is not recommended (Grade D, LoE 4), due to inconsistent procedure-specific evidence for analgesic benefit in the postoperative period

Clinical Practice

  • The injection of botulinum toxin for pain after haemorrhoid surgery is not performed routinely in clinical practice

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Overall pain at rest was significantly lower with Botox versus glyceryl trinitrate (GTN) ointment (p<0.01), although overall pain during defecation was similar between groups (
  • Significantly fewer nimesulide tablets (100 mg) were consumed by patients receiving Botox compared with those treated with GTN ointment (p<0.05;
  • The incidence of adverse events potentially related to drug treatment was significantly lower with Botox compared with GTN (p<0.03; 5 patients receiving GTN reported transient moderate-to-severe headaches) (
  • The time to complete healing of perianal wounds was similar with Botox and GTN ointment (
  • The time to first defecation was similar in groups treated with either Botox injection or GTN ointment (
  • The incidence of anal incontinence was comparable between groups receiving either Botox injection or GTN ointment (
  • The incidence of urinary retention was not significantly different between groups treated with either Botox injection or GTN ointment (
  • The time to return to work was similar with Botox and GTN (
  • There was no significant difference in the length of hospital stay in a Botox group versus a GTN group (
  • Study details Patti 2006 Click here for more information

PROSPECT Recommendations

  • Flavonoids are not recommended (Grade D, LoE 4) because of limited and inconclusive procedure-specific evidence

Clinical Practice

  • None cited

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

PROSPECT Recommendations

  • Laxatives are recommended (Grade A) in the days prior to surgery, as an adjunct to analgesic therapy, based on procedure-specific evidence (LoE 1 and 2)

Clinical Practice

  • Stool softeners are an alternative to laxatives in clinical practice

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Two studies out of two demonstrated that laxatives caused a significant reduction in pain scores on defecation compared with placebo/control London 1987 Click here for more information
  • There was a significant reduction in VAS pain scores on day 10 with Plantago ovata compared with control (p<0.01), but not on day 20 (
  • In one study, oral paracetamol requirements after defecation were significantly lower with lactulose compared with placebo (p<0.01), although IM papaveretum consumption was not significantly different between groups, and analgesic requirements before defecation (papaveretum and paracetamol) were similar (
  • Two studies out of two demonstrated a shorter length of hospital stay with laxatives compared with placebo/control (
  • The tenesmus rate in patients in a Plantago ovata group was significantly lower than in patients in a control group (p<0.01;
  • The time to first bowel action was significantly shorter in patients receiving lactulose compared with patients receiving placebo (p=0.01), although the number of bowel actions in the first week was not significantly different between groups (p=0.05;
  • There were no significant differences between groups treated with lactulose and placebo in VAS or VRS pain scores in the 24 h preceding defecation on POD 1–3 (
  • Study details London 1987 Click here for more information

PROSPECT Recommendations

  • Oral metronidazole is recommended (Grade A) as an adjunct to analgesic therapy based on procedure-specific evidence (LoE 1)

Clinical Practice

  • None cited

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Three out of four studies demonstrated a reduction in pain scores with metronidazole compared with placebo/no treatment Click here for more information
  • In two out of three studies, the time to return to work or normal activities was significantly shorter with metronidazole compared with placebo/no treatment Click here for more information
  • In one study out of two, wound healing occurred significantly faster with metronidazole compared with placebo/no treatment; the second study also showed faster wound healing with metronidazole, but no statistics were reported Click here for more information
  • VAS pain scores were significantly lower with metronidazole + glyceryl trinitrate (GTN) + lactulose compared with placebo on days 2, 3 (both p<0.05), 6 and 7 (both p<0.01), but not at 24 h, or on days 4 and 5. Pain after defecation was significantly lower with metronidazole + GTN + lactulose compared with placebo after the 1st and 2nd defecations (both p<0.05), but not after the 3rd, 4th or 5th (
  • Time to return to work or normal activities was significantly shorter in patients receiving metronidazole + GTN + lactulose compared with those receiving placebo (p<0.05;
  • In four studies out of four, rescue analgesic requirements were not significantly different in groups receiving metronidazole or placebo/no treatment Click here for more information
  • Analgesic requirements (IV diclofenac 100 mg, then nimesulide 100 mg tablets as needed) were not significantly different between patients receiving metronidazole + GTN + lactulose compared with those receiving placebo (
  • Time to healing was not significantly different between patients receiving metronidazole + GTN + lactulose and those receiving placebo (
  • Metronidazole versus placebo/no treatment
  • Study details Click here for more information
  • Metronidazole + glyceryl trinitrate (GTN) + lactulose versus placebo
  • Study details Di Vita 2003 Click here for more information

PROSPECT Recommendations

  • The use of an anal sphincter relaxant is not recommended (Grade D, LoE 4) for analgesia based on limited procedure-specific evidence

Clinical Practice

  • Anal sphincter relaxants are not commonly used in clinical practice

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Pain scores at 4 h, maximum pain during the first 24 h after surgery, and pain scores on POD 2 were similar in patients receiving a trimebutine suppository and those receiving no suppository (
  • There were no significant differences in rescue analgesic requirements (number of ketoprofen tablets required and number of patients requiring IM pethidine injection) with or without a trimebutine suppository (
  • Study details Ho 1997a Click here for more information

PROSPECT Recommendations

  • Topical glyceryl trinitrate is not recommended (Grade D, LoE 4) due to inconsistent procedure-specific data
  • Topical calcium channel blocker is not recommended (Grade D, LoE 4) due to limited procedure-specific evidence
  • Calcium alginate dressings are not recommended (Grade D, LoE 4) due to limited procedure-specific evidence

Clinical Practice

  • Two studies involving the use of topical glyceryl trinitrate (GTN) showed an improvement in wound healing
  • Any effort to decrease postoperative oedema can be beneficial for postoperative analgesia

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • Topical ointments
  • Haemostatic dressings

PROSPECT Recommendations

  • No recommendation can be made regarding postoperative local perianal infiltration, due to limited and inconsistent procedure-specific evidence (LoE 4)

Clinical Practice

  • Haemorrhoid surgery is a short procedure, and therefore the effects of LA infiltration may be most beneficial when administered pre-operatively
  • Epinephrine is commonly used for LA infiltration, as it is often combined in a preparation with lidocaine and some other LAs

Transferable Evidence

  • None cited

Haemorrhoid surgery-specific evidence

  • In one study out of one, the time to the first demand for IM opiate analgesia was significantly longer with perianal bupivacaine infiltration compared with placebo (p<0.01;
  • In one study out of one, complete wound healing at 6 weeks was observed in all patients treated with both perianal bupivacaine infiltration and placebo (
  • In one study out of two, there was no significant difference in pain scores between groups receiving perianal bupivacaine infiltration or placebo on POD 1 and 2 ( Marsh 1993 Click here for more information
  • In two out of two studies, there were no significant differences in rescue analgesic requirements in patients treated with either perianal bupivacaine infiltration or placebo Chester 1990 Click here for more information
  • In one study out of one, the time to first bowel movement was similar with perianal bupivacaine infiltration and placebo (
  • A similar incidence of urinary retention was reported with both perianal bupivacaine infiltration and placebo (
  • The length of hospital stay was not significantly different between groups undergoing perianal bupivacaine infiltration or placebo infiltration (
  • Patient satisfaction with analgesia was similar with perianal bupivacaine infiltration and placebo (
  • Study details Chester 1990 Click here for more information