Herniorraphy

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Summary Recommendations 
The recommendations of the PROSPECT Working Group are graded A–D, based on the level of evidence from the studies, which is in accordance with the Oxford Centre for Evidence-Based Medicine (CEBM website accessed Dec 2003, Sackett 2000). In the context of PROSPECT, recommendations based on procedure-specific evidence are grade A (randomised clinical trials), those based on transferable evidence are grade B (randomised clinical trials) or grade C (retrospective studies or case series) and those based on clinical practice are grade D (Click here for further information on levels of evidence and grades of recommendation).

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.

The following pre-, intra- and postoperative interventions have been evaluated for the management of postoperative pain following herniorraphy:

Pre-operative

Recommended

Systemic 

  • Conventional NSAIDs (Grade A) or COX-2-selective inhibitors (Grade A) 

Local anaesthetic techniques

  • Inguinal nerve block/field block/infiltration, pre-operatively and/or intra-operatively (Grade A)
  • Long-acting local anaesthetics (Grade D) 

Not recommended

Systemic

  • Clonidine (Grade D)
  • Corticosteroid (Grade D)
  • Gabapentin/pregabalin (Grade D)
  • Ketamine (Grade D)

Local anaesthetic techniques

  • Epinephrine (Grade A), dextran (Grade D) or corticosteroid (Grade D) as part of a local anaesthetic solution
  • Paravertebral nerve block (Grade D)

Other local analgesics

  • Wound infiltration with clonidine (Grade D)
  • Wound infiltration with conventional NSAIDs (Grade A)
  • Topical conventional NSAIDs (Grade D) 
     

Intra-operative

Recommended 

Local anaesthetic techniques

  • Inguinal nerve block/field block/infiltration, pre-operatively and/or intra-operatively (Grade A)
  • Long-acting local anaesthetics (Grade D)

Operative anaesthetic techniques

  • Local anaesthesia ± sedation OR general anaesthesia in combination with local anaesthetic techniques (inguinal nerve block/field block/infiltration) (Grade A)
  • Long-acting local anaesthetics (Grade D)

Operative techniques

  • Open or laparoscopic surgery (Grade D)
  • Mesh techniques (Grade A) – no recommendations for one particular open mesh technique, prosthesis type or mesh fixation technique over another due to limited available pain data  

Not recommended 

Systemic

  • Clonidine (Grade D)
  • Gabapentin/pregabalin (Grade D)
  • Ketamine (Grade D)

Local anaesthetic techniques

  • Epinephrine (Grade A), dextran (Grade D) or corticosteroid (Grade D) as part of a local anaesthetic solution
  • Local anaesthetic instillation (no needles) at closure (Grade D)
  • Extraperitoneal instillation of local anaesthetic during laparoscopic surgery (Grade A)
  • Paravertebral nerve block (Grade D)

Other local analgesics

  • Wound infiltration with clonidine (Grade D)
  • Wound infiltration with conventional NSAIDs (Grade A)
  • Wound infiltration with strong opioid (Grade A)

Operative anaesthetic techniques

  • Epidural anaesthesia (Grade D)
  • Spinal anaesthesia (Grade D)

Operative techniques

  • Open non-mesh surgery (Grade A)

Nerve section/cryoanalgesia techniques

  • Surgical division of the ilioinguinal nerve (Grade A)
  • Cryoanalgesia (Grade A)  

Postoperative

Recommended 

Systemic

  • Conventional NSAIDs (grade A) or COX-2-selective inhibitors (grade A)
  • Paracetamol, for routine pain therapy in combination with conventional NSAIDs/COX-2-selective inhibitors (Grade B)
  • Weak opioids for moderate-intensity pain when conventional NSAIDs/COX-2-selective inhibitors plus paracetamol are not sufficient or are contraindicated (Grade B)
  • Strong opioids as rescue analgesia only (for high-intensity pain), in addition to non-opioid analgesia (Grade B)  

Not recommended 

Systemic

  • Gabapentin/pregabalin (Grade D)
  • Ketamine (Grade D)

Local anaesthetic techniques

  • Continuous infusion with local anaesthetic by a catheter in the wound (Grade D)
  • Single/repeat dose of local anaesthetic by a catheter in the wound (Grade A)
  • Postoperative subcutaneous infiltration with local anaesthetic (Grade D)

Non-pharmacological techniques

  • TENS (Grade A)

See Overall PROSPECT recommendations for the overall strategy for managing pain after herniorraphy 


 

Overall PROSPECT Recommendations

Recommended
Pre-/intra-operative
  • Local anaesthesia ± sedation OR general anaesthesia in combination with local anaesthetic techniques (inguinal nerve block/field block/infiltration)
  • Long-acting local anaesthetics in preference to short-acting local anaesthetics
  • Open or laparoscopic surgery, depending on factors other than postoperative pain
  • Mesh techniques in preference to non-mesh techniques
Postoperative
0–6 hours (including the post anaesthetic care unit [PACU])
For postoperative analgesia in addition to that provided by intra-operative local anaesthetics:
  • Base medication: conventional NSAIDs or COX-2-selective inhibitors (use weak opioids when conventional NSAIDs/COX-2-selective inhibitors are contraindicated), combined with paracetamol
  • Add weak opioid when VAS>30<50*
  • Add strong opioid when VAS³50*
Postoperative Beyond 6 h
  • Continue base medication: conventional NSAIDs or COX-2-selective inhibitors (use weak opioids when conventional NSAIDs/COX-2-selective inhibitors are contraindicated), combined with paracetamol
  • Add weak opioid when VAS>30<50*
  • Add strong opioid when VAS³50*

* VAS³50, on a scale of 1–100 mm = high-intensity pain
VAS>30<50, on a scale of 1–100 mm = moderate-intensity pain
VAS£30, on a scale of 1–100 mm = low-intensity pain

Not recommended

  • Spinal anaesthesia
  • Epidural anaesthesia
  • Systemic clonidine, corticosteroid, gabapentin/pregabalin or ketamine
  • Epinephrine as part of a local anaesthetic solution
  • Intra-operative wound instillation with local anaesthetic
  • Paravertebral nerve block
  • Postoperative single/repeat wound injection, or postoperative continuous wound infusion, with local anaesthetic
  • Wound infiltration using conventional NSAIDs, clonidine or strong opioids
  • Topical conventional NSAIDs
  • Nerve section, cryoanalgesia techniques or TENS


 

Description of studies 
Literature search

Systematic review of the literature from 1966–January 2004 using MEDLINE and EmBASE, following the protocol of the Cochrane Collaboration:

  • Inclusion of randomised studies in English assessing analgesic interventions in herniorraphy in adults, and reporting pain on a linear analogue scale
  • Identification of 243 studies of peri-operative interventions for postoperative pain following herniorraphy
  • 122 studies included (Click here for further information)
  • 121 studies excluded (Click here for further information)
  • The most common reason for exclusion was the absence of postoperative pain scores (77 studies). Studies of analgesic interventions following laparoscopic herniorraphy (four studies) were excluded from the systematic review because there is evidence that laparoscopic herniorraphy is associated with a different postoperative pain profile to open herniorraphy (see Intra-operative, Operative techniques). These laparoscopic herniorraphy studies are presented as transferable evidence. (Click here for further information about excluded studies)

Transferable evidence

In PROSPECT, procedure-specific evidence is usually supplemented with transferable evidence (evidence from procedures with similar pain profiles). However, due to the nature of herniorraphy, evidence is not directly transferable from any other procedure; therefore this section includes studies and reviews of a variety of surgical procedures, where appropriate, to address information not covered in the systematic review. This section also includes a small number of studies of analgesic interventions following laparoscopic herniorraphy. 

Local Anaesthetic Techniques 

This section includes studies of local anaesthetics administered to provide postoperative analgesia (i.e. where each group received the same anaesthetic background). For studies of local anaesthesia versus other types of anaesthesia, see Intra-operative, Operative Anaesthetic Techniques

PROSPECT Recommendations

  • Local anaesthetic injection techniques (inguinal nerve block/field block/infiltration), administered pre-operatively or intra-operatively, or both, are recommended (Grade A) because they reduce early postoperative pain and supplementary analgesic use compared with placebo. The effect of pre-operative administration is comparable to post-incisional administration
  • There are insufficient data to recommend (Grade D) one injection technique (inguinal nerve block/field block/infiltration), or combination, in preference to another
  • Local anaesthetic instillation administered at closure cannot be recommended at this time, despite some evidence for its analgesic efficacy, because of limited data (grade D)
  • Long-acting local anaesthetics are recommended in preference to short-acting local anaesthetics (Grade D)
  • Addition of dextran or corticosteroid to local anaesthetic solution is not recommended (Grade D) because of limited procedure-specific evidence

Clinical Practice

  • Long-acting local anaesthetics are preferred to short-acting local anaesthetics for analgesia by local injection
  • In herniorraphy studies of local anaesthetic injection techniques, methodology is inconsistently described, and terminology is inconsistently used. In addition, studies directly comparing one local anaesthetic injection technique with another are lacking. For these reasons, no conclusion about the relative benefits of one technique, or combination of techniques (inguinal nerve block/field block/infiltration), can be made at this time

Transferable Evidence from Other Procedures

  • 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 Møiniche et al 1998
  • 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 Møiniche et al 1998

Herniorraphy-Specific Evidence

PROSPECT Recommendations

  • Addition of epinephrine to local anaesthetic solution is not recommended because of a lack of additional or prolonged analgesic effect from limited procedure-specific data (Grade A)

Clinical Practice

  • Epinephrine may result in undesirable cardiovascular side-effects

Transferable Evidence from Other Procedures - Study information

Herniorraphy-Specific Evidence - Study information

  • Intra-operative wound instillation with epinephrine and local anaesthetic was of no significant benefit over local anaesthetic alone for reducing postoperative pain scores during 1–20 h, or for reducing analgesic requirements, for increasing the time to first analgesic request (n=17) Bays et al 1991

PROSPECT Recommendations

  • Paravertebral nerve block is not recommended (Grade D) because it has only a marginal analgesic benefit over other local anaesthetic techniques (nerve block/field block/infiltration) and is a more complex technique

Clinical Practice

  • Clinical experience with the paravertebral nerve block is not widespread. This technique is considered to be more complex, and thus it may be associated with a higher incidence of complications than other local anaesthetic techniques (nerve block/field block/infiltration)

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Paravertebral nerve block was superior to peripheral nerve block for reducing the proportion of patients requiring supplementary analgesia in the PACU (p=0.002; n=46) Klein et al 2002
  • Paravertebral nerve block was superior to peripheral nerve block for reducing the incidence of PONV in the PACU (p<0.001; n=46) Klein et al 2002
  • Paravertebral nerve block and peripheral nerve block were not significantly different for VAS pain scores at rest, on movement and on coughing in the PACU, or at 2, 6, 12, 18, 24 and 48 h (n=46) Klein et al 2002
  • There was no significant difference between paravertebral nerve block and peripheral nerve block for the proportion of patients requiring supplementary analgesics in the 72-h follow-up period, or the time to first analgesic request (n=46) Klein et al 2002

PROSPECT Recommendations

  • Gabapentin/pregabalin cannot be recommended at this time due to the lack of procedure-specific evidence (Grade D), despite analgesic efficacy in other procedures

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • Studies of gabapentin and pregabalin in mastectomy, abdominal surgery, laparoscopic cholecystectomy and spinal surgery showed reductions in postoperative pain and supplementary analgesic requirements for at least 24 h Dahl et al 2004

Herniorraphy-Specific Evidence

  • [None cited]

PROSPECT Recommendations

  • Pre-operative ketamine cannot be recommended at this time due to a lack of procedure-specific evidence, and due to associated side-effects that may hinder early ambulation (Grade D), despite some evidence of analgesic efficacy in other procedures

Clinical Practice

  • Ketamine is associated with a risk of adverse effects on the central nervous system

Transferable Evidence from Other Procedures

  • Studies of ketamine in abdominal, orthopaedic, gastric, hepatic and renal surgery showed a reduction in postoperative pain and opioid use when used as an adjuvant to morphine, either epidurally or intravenously Subramaniam et al 2004

Herniorraphy-Specific Evidence

  • [None cited]

 PROSPECT Recommendations

  • Pre-operative systemic clonidine is not recommended because of limited procedure-specific evidence and potential side-effects, which may delay early ambulation (Grade D)

Clinical Practice

  • Clonidine is associated with side-effects, including hypotension, sedation, dizziness and bradycardia

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence

PROSPECT Recommendations

  • Pre-operative corticosteroid is not recommended due to limited procedure-specific evidence and because herniorraphy per se is not associated with a high incidence of PONV (Grade D)

Clinical Practice

  • Herniorraphy is not associated with a high incidence of PONV

Transferable Evidence from Other Procedures

  • Systemic corticosteroid administration is recommended to prevent PONV in procedures associated with high emetic effects Apfel et al 2004

Herniorraphy-Specific Evidence

  • Pre-operative intravenous dexamethasone showed no benefit over placebo for reducing VAS pain scores overall, and at 4, 8, 12, 16, 20 or 24 h (n=60) Tan et al 2001
  • Pre-operative intravenous dexamethasone was not significantly different from placebo for supplementary analgesic requirements or time to first analgesic request (n=60) Tan et al 2001
  • Pre-operative intravenous dexamethasone was of no benefit over placebo for reducing the incidence of PONV (n=60) Tan et al 2001

PROSPECT Recommendations

  • Pre-operative COX-2-selective inhibitors are recommended based on their analgesic efficacy (grade A) and, as with all analgesics, should be administered in time to secure sufficient analgesia following the procedure
  • Since pre-/intra-operative local anaesthetic techniques provide sufficient analgesia in the immediate postoperative period (grade A), COX-2-selective inhibitors can be initiated orally in the early (1-3 hours) postoperative period
  • COX-2-selective inhibitors may be preferred to conventional NSAIDs in the peri-operative setting, in patients who have an increased risk of bleeding, or who are at risk of gastroduodenal ulcer/erosion (grade B)
  • The use of COX-2-selective inhibitors should depend upon assessment of individual patient risks (cardiovascular morbidity, actual or recent gastroduodenal ulcer history, renal function and hepatic function [grade B] or aspirin-sensitive asthma [grade D])

Clinical Practice

  • Rofecoxib has been withdrawn from the market, and marketing of valdecoxib has been suspended in most countries

Transferable Evidence from Other Procedures

  • COX-2-selective inhibitors provide similar postoperative analgesia to conventional NSAIDs Rømsing et al 2004
  • Randomised endoscopic trials in healthy 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 Harris et al 2001
  • Studies in healthy volunteers demonstrated that COX-2-selective inhibitors had no effect on platelet aggregation Greenberg et al 2000
  • A randomised clinical trial showed that the COX-2-selective inhibitor rofecoxib was associated with significantly less intra-operative blood loss than the conventional NSAID diclofenac in patients undergoing abdominal or vaginal hysterectomy or breast surgery Hegi et al 2004
  • 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 Bavbek et al 2004
  • A study to assess the safety of the COX-2-selective inhibitors parecoxib and valdecoxib following noncardiac 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) (in press, Anesthesiology)
  • 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 Nussmeier et al 2005
  • 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 EMEA 2004a
  • 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. Elderly females, with autoimmune disease, and taking other potentially hepatotoxic drugs, may be most susceptible O'Connor et al 2003
  • 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 Cheng et al 2004
  • COX-2-selective inhibitors and conventional NSAIDs may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication Cheng et al 2004
  • Although there is some concern that COX-2-selective inhibitors may impair wound healing, evidence from animal and clinical studies is conflicting Blomme et al 2003

Herniorraphy-Specific Evidence

  • Oral rofecoxib administered pre- plus postoperatively significantly reduced postoperative pain scores, compared with placebo, at rest at 1 h (p<0.05) but there was no benefit at 30 min or at the time of first analgesic request (n=60) Ma et al 2004
  • Rofecoxib administered pre- plus postoperatively significantly reduced requirements for supplementary hydromorphone in the PACU (p<0.05) (n=60) Ma et al 2004
  • Rofecoxib administered pre- plus postoperatively did not significantly reduce the incidence of PONV compared with placebo (low incidence in both groups) (n=60) Ma et al 2004

PROSPECT Recommendations

  • Pre-operative conventional NSAIDs are recommended, based on their analgesic efficacy (grade A), and as with all analgesics should be administered in time to secure sufficient analgesia following the procedure
  • Since pre-/intra-operative local anaesthetic infiltration techniques provide sufficient analgesia in the immediate postoperative period (grade A), conventional NSAIDs can be initiated orally in the early (1-3 hours) postoperative period
  • Conventional NSAIDs are not recommended in patients who have an increased risk of bleeding, or who are at risk of gastroduodenal ulcer/erosion (grade B)
  • The use of conventional NSAIDs should depend upon assessment of individual patient risks (bleeding complications, cardiovascular morbidity, actual or recent gastroduodenal ulcer history, aspirin-sensitive asthma, renal function and hepatic function) (grade B)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • Pre-operative ibuprofen was similar to intra-operative ketorolac for VAS pain scores over the first 24 h, at discharge and after discharge, and for the proportion of patients requiring postoperative supplementary analgesia (n=70) Mixter et al 1998
  • Conventional NSAIDs have proven analgesic efficacy in a variety of surgical procedures Barden et al 2004
  • One randomised trial in patients undergoing transurethral prostatectomy showed that diclofenac did not affect total blood loss compared with placebo Bricker et al 1987
  • Randomised endoscopic trials in healthy 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 Harris et al 2001
  • 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 Greer et al 1999
  • 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 Marret et al 2003
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction Niemi et al 1997
  • 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 Forrest et al 2002
  • A randomised clinical trial showed that the conventional NSAID diclofenac was associated with significantly greater intra-operative blood loss than the COX-2-selective inhibitor rofecoxib in patients undergoing abdominal or vaginal hysterectomy or breast surgery Hegi et al 2004
  • Aspirin and conventional NSAIDs can induce asthma attacks in patients with aspirin-exacerbated respiratory disease Stevenson 2004
  • 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. Elderly females, with autoimmune disease, and taking other potentially hepatotoxic drugs, may be most susceptible O'Connor et al 2003
  • 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 Cheng et al 2004
  • Conventional NSAIDs and COX-2-selective inhibitors may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication Cheng et al 2004

Herniorraphy-Specific Evidence

  • Pre-operative conventional NSAIDs reduced postoperative pain scores compared with placebo or no treatment Ben-David et al 1996 Click here for more information
  • Pre-operative conventional NSAIDs reduced supplementary analgesic requirements compared with placebo or no treatment Dueholm et al 1989 Click here for more information
  • Tenoxicam 10 mg was not significantly different from 20 mg for pain scores at rest or on movement at 2, 9 and 24 h and for supplementary analgesic requirements (n=30) Lin et al 1998
  • Pre-operative intravenous ketorolac and rectal diclofenac were similar for pain scores at 2, 6 and 24 h and on day 3, for use of supplementary diclofenac, and for the incidence of PONV (n=108) Lau et al 2002
  • Intravenous and intramuscular ketorolac were superior to oral ketorolac for reducing pain scores and supplementary analgesic requirements, but there was no significant difference between intravenous and intramuscular ketorolac or between rectal and intramuscular diclofenac Ben-David et al 1996 Click here for more information

PROSPECT Recommendations

  • Wound infiltration with clonidine is not recommended because of limited procedure-specific data and because of potential side-effects, which may delay early ambulation (Grade D)

Clinical Practice

  • Clonidine is associated with side-effects, including hypotension, sedation, dizziness and bradycardia

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Wound infiltration with clonidine showed a significant benefit for reducing pain scores compared with placebo at 2 h, but there was no significant difference at other times Connelly et al 1999 Click here for more information
  • Wound infiltration with clonidine was of no significant benefit for reducing supplementary analgesic requirements compared with placebo (n=30) Connelly et al 1999
  • Wound infiltration with clonidine was of no significant benefit over systemic administration for reducing pain scores or supplementary analgesic requirements Connelly et al 1999 Click here for more information

PROSPECT Recommendations

  • Pre-operative wound infiltration with conventional NSAIDs is not recommended (grade A) because of inconclusive evidence of an analgesic benefit, compared with systemic administration

Clinical Practice

  • The potential for conventional NSAIDs, administered by wound infiltration, to adversely affect platelet function and wound healing must be considered

Transferable Evidence from Other Procedures

  • One randomised trial in patients undergoing transurethral prostatectomy showed that diclofenac did not affect total blood loss compared with placebo Bricker et al 1987
  • A systematic review of the postoperative analgesic effect of local infiltration with conventional NSAIDs showed little difference between wound infiltration and systemic administration Rømsing et al 2000
  • 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 Greer et al 1999
  • 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 Marret et al 2003
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction Niemi et al 1997
  • 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 Forrest et al 2002
  • A randomised clinical trial showed that the conventional NSAID diclofenac was associated with significantly greater intra-operative blood loss than the COX-2-selective inhibitor rofecoxib in patients undergoing abdominal or vaginal hysterectomy or breast surgery Hegi et al 2004

Herniorraphy-Specific Evidence - Study information

PROSPECT Recommendations

  • Pre-operative topical conventional NSAIDs cannot be recommended at this time (Grade D) because of limited procedure-specific data

Clinical Practice

  • The potential for conventional NSAIDs, administered topically, to adversely affect platelet function and wound healing must be considered

Transferable Evidence from Other Procedures

  • One randomised trial in patients undergoing transurethral prostatectomy showed that diclofenac did not affect total blood loss compared with placebo Bricker et al 1987
  • A systematic review of the postoperative analgesic effect of local infiltration with conventional NSAIDs showed little difference between wound infiltration and systemic administration Rømsing et al 2000
  • 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 Greer et al 1999
  • 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 Marret et al 2003
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction Niemi et al 1997
  • 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 Forrest et al 2002
  • A randomised clinical trial showed that the conventional NSAID diclofenac was associated with significantly greater intra-operative blood loss than the COX-2-selective inhibitor rofecoxib in patients undergoing abdominal or vaginal hysterectomy or breast surgery Hegi et al 2004

Herniorraphy-Specific Evidence - Study information

  • Topical piroxicam was superior to placebo for reducing VAS pain scores during 0–4 h (p<0.05) but there was no significant difference during 4–24 h (n=27) O'Hanlon et al 1996
  • Topical piroxicam was superior to placebo for reducing postoperative supplementary analgesic requirements during 0–24 h (p<0.005) but not during 4–24 h, and piroxicam did not increase the time to first analgesia (n=27) O'Hanlon et al 1996
  • Topical application of NSAIDs was equally effective compared with inguinal nerve block for reducing 0–24 h pain scores at rest, reducing analgesic requirements and for increasing the time to first analgesic request (n=30) O'Hanlon et al 1996

PROSPECT Recommendations

  • Intra-operative clonidine is not recommended due to limited procedure-specific evidence and potential side-effects, which may delay early ambulation (Grade D)

Clinical Practice

  • Clonidine is associated with side-effects, including hypotension, sedation, dizziness and bradycardia

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Clonidine significantly increased VAS pain scores compared with placebo at rest at 24 h (p<0.05), and there was no significant benefit in the PACU or at 6 h, or on coughing at any time (n=31) Elliott et al 1997
  • Intra-operative systemic clonidine was of no significant benefit over placebo for reducing postoperative analgesic requirements (n=31) Elliott et al 1997

PROSPECT Recommendations

  • Gabapentin/pregabalin cannot be recommended at this time due to the lack of procedure-specific evidence (Grade D), despite analgesic efficacy in other procedures

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • Studies of gabapentin and pregabalin in mastectomy, abdominal surgery, laparoscopic cholecystectomy and spinal surgery showed reductions in postoperative pain and supplementary analgesic requirements for at least 24 h Dahl et al 2004

Herniorraphy-Specific Evidence

  • [None cited]

PROSPECT Recommendations

  • Intra-operative ketamine cannot be recommended at this time (Grade D) due to a lack of procedure-specific evidence, and due to associated side-effects that may hinder early ambulation, despite some evidence of analgesic efficacy in other procedures

Clinical Practice

  • Ketamine is associated with a risk of adverse effects on the central nervous system

Transferable Evidence from Other Procedures

  • Studies of ketamine in abdominal, orthopaedic, gastric, hepatic and renal surgery showed a reduction in postoperative pain and opioid use when used as an adjuvant to morphine, either epidurally or intravenously Subramaniam et al 2004

Herniorraphy-Specific Evidence

  • [None cited]

Local Anaesthetic Techniques 

This section includes studies of local anaesthetics administered to provide postoperative analgesia (i.e. where each group received the same anaesthetic background). For studies of local anaesthesia versus other types of anaesthesia, see Intra-operative, Operative Anaesthetic Techniques 

PROSPECT Recommendations

  • Local anaesthetic injection techniques (inguinal nerve block/field block/infiltration), administered pre-operatively or intra-operatively, or both, are recommended (Grade A) because they reduce early postoperative pain and supplementary analgesic use compared with placebo. The effect of pre-operative administration is comparable to post-incisional administration
  • There are insufficient data to recommend (Grade D) one injection technique (inguinal nerve block/field block/infiltration), or combination, in preference to another
  • Local anaesthetic instillation administered at closure cannot be recommended at this time, despite some evidence for its analgesic efficacy, because of limited data (Grade D)
  • Long-acting local anaesthetics are recommended in preference to short-acting local anaesthetics (Grade D)
  • Addition of dextran or corticosteroid to local anaesthetic solution is not recommended (Grade D) because of limited procedure-specific evidence

Clinical Practice

  • Long-acting local anaesthetics are preferred to short-acting local anaesthetics for analgesia by local injection
  • In herniorraphy studies of local anaesthetic injection techniques, methodology is inconsistently described, and terminology is inconsistently used. In addition, studies directly comparing one local anaesthetic injection technique with another are lacking. For these reasons, no conclusion about the relative benefits of one technique, or combination of techniques (inguinal nerve block/field block/infiltration), can be made at this time

Transferable Evidence from Other Procedures

  • 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 Møiniche et al 1998
  • 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 Møiniche et al 1998

Herniorraphy-Specific Evidence - Study information

PROSPECT Recommendations

  • Addition of epinephrine to local anaesthetic solution is not recommended because of a lack of additional or prolonged analgesic effect from limited procedure-specific data (Grade A)

Clinical Practice

  • Epinephrine may result in undesirable cardiovascular side-effects

Transferable Evidence from Other Procedures - Study information

Herniorraphy-Specific Evidence - Study information

  • Intra-operative wound instillation with epinephrine and local anaesthetic was of no significant benefit over local anaesthetic alone for reducing postoperative pain scores during 1–20 h, for reducing analgesic requirements, or for increasing the time to first analgesic request (n=17) Bays et al 1991

PROSPECT Recommendations

  • Paravertebral nerve block is not recommended (Grade D) because it has only a marginal analgesic benefit over other local anaesthetic techniques (nerve block/field block/infiltration) and is a more complex technique

Clinical Practice

  • Clinical experience with the paravertebral nerve block is not widespread. This technique is considered to be more complex, and thus it may be associated with a higher incidence of complications than other local anaesthetic techniques (nerve block/field block/infiltration)

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Paravertebral nerve block was superior to peripheral nerve block for reducing the proportion of patients requiring supplementary analgesia in the PACU (p=0.002; n=46) Klein et al 2002
  • Paravertebral nerve block was associated with a lower incidence of PONV in the PACU compared with peripheral nerve block (p<0.001; n=46) Klein et al 2002
  • Paravertebral nerve block and peripheral nerve block were not significantly different for VAS pain scores at rest, on movement and on coughing in the PACU, or at 2, 6, 12, 18, 24 and 48 h (n=46) Klein et al 2002
  • There was no significant difference between paravertebral nerve block and peripheral nerve block for the proportion of patients requiring supplementary analgesics in the 72-h follow-up period, or the time to first analgesic request (n=46) Klein et al 2002

PROSPECT Recommendations

  • Extraperitoneal instillation with local anaesthetic is not relevant for open herniorraphy
  • Extraperitoneal instillation with local anaesthetic is not recommended in laparoscopic herniorraphy because of a lack of analgesic effect (Grade A)

Clinical Practice

  • There is little clinical experience with extraperitoneal instillation and the technique is poorly defined

Transferable Evidence from Other Procedures - study information

Herniorraphy-Specific Evidence

  • – None cited for open herniorraphy– For data in laparoscopic herniorraphy, see the transferable evidence below

PROSPECT Recommendations

  • Wound infiltration with clonidine is not recommended due to limited procedure-specific data and potential side-effects that can delay early ambulation (Grade D)

Clinical Practice

  • Clonidine is associated with side-effects, including hypotension, sedation, dizziness and bradycardia

Transferable Evidence from Other Procedures 

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Wound infiltration with clonidine was superior to intramuscular clonidine for reducing pain scores, but a significant benefit was only evident at 24 h; there was no significant benefit for reducing supplementary analgesic requirements Elliott et al 1997 Click here for more information
  • Wound infiltration with clonidine showed no significant benefit compared with placebo for reducing VAS pain scores at rest and on coughing in recovery, at 6 h and at 24 h (n=31) Elliott et al 1997
  • Wound infiltration with clonidine showed no significant benefit compared with placebo for reducing supplementary analgesic requirements (n=31) Elliott et al 1997

PROSPECT Recommendations

  • Intra-operative wound infiltration with conventional NSAIDs is not recommended (grade A) because of a limited analgesic benefit compared with systemic administration

Clinical Practice

  • The potential for conventional NSAIDs, administered by wound infiltration, to adversely affect platelet function and wound healing must be considered

Transferable Evidence from Other Procedures

  • One randomised trial in patients undergoing transurethral prostatectomy showed that diclofenac did not affect total blood loss compared with placebo Bricker et al 1987
  • A systematic review of the postoperative analgesic effect of local infiltration with conventional NSAIDs showed little difference between wound infiltration and systemic administration Rømsing et al 2000
  • 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 Greer et al 1999
  • 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 Marret et al 2003
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction Niemi et al 1997
  • 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 Forrest et al 2002
  • A randomised clinical trial showed that the conventional NSAID diclofenac was associated with significantly greater intra-operative blood loss than the COX-2-selective inhibitor rofecoxib in patients undergoing abdominal or vaginal hysterectomy or breast surgery Hegi et al 2004

Herniorraphy-Specific Evidence -study information

PROSPECT Recommendations

  • Wound infiltration with strong opioids is not recommended because of conflicting procedure-specific evidence for its analgesic efficacy (Grade A). In addition, strong opioids are not recommended for routine analgesic treatment in herniorraphy because of potential side-effects (Grade D)

Clinical Practice

  • Strong opioids are associated with adverse effects, including respiratory depression, nausea, vomiting, sedation, confusion, paralytic ileus and urinary retention

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - study information

PROSPECT Recommendations

  • Local anaesthesia (inguinal nerve block/field block/infiltration techniques), with or without intravenous sedation, is recommended (Grade A) because it decreases postoperative pain and provides additional recovery benefits compared with spinal anaesthesia or general anaesthesia
  • Long-acting local anaesthetics are recommended (Grade D) in preference to short-acting local anaesthetics

Clinical Practice

  • Long-acting local anaesthetics are preferred to short-acting local anaesthetics
  • For all regional anaesthesia techniques, there are procedure-specific failure rates between 2 and 10%, and conversion to general anaesthesia may be required
  • Local practices and cultural differences influence the choice of anaesthetic technique for herniorraphy

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - study information

PROSPECT Recommendations

  • When general anaesthesia is used, its combination with local anaesthetic techniques is recommended to decrease postoperative pain (Grade A)
  • Spinal anaesthesia provides good anaesthesia and early postoperative analgesia. Spinal anaesthesia cannot be recommended for routine use (Grade D - majority vote from the prospect Working Group) because of postoperative side-effects that can delay early ambulation, such as urinary retention and hypotension
  • Epidural anaesthesia is not recommended (Grade D)
  • Local anaesthetic techniques (inguinal nerve block/field block/infiltration) are recommended (Grade A) because they provide good postoperative analgesia, rapid recovery, and few side-effects, but the need for intravenous sedation has to be considered (see Intra-operative anaesthetic techniques, Local anaesthesia)
  • Addition of clonidine or neostigmine to local anaesthetic solution for spinal anaesthesia is not recommended due to limited procedure-specific evidence. In addition, potential side-effects of clonidine (Grade D) and neostigmine (Grade A) may hinder early ambulation

Clinical Practice

  • For all regional anaesthesia techniques, there are procedure-specific failure rates between 2 and 10%, and conversion to general anaesthesia may be required
  • Local practices and cultural differences influence the choice of anaesthetic technique for herniorraphy
  • Clonidine is associated with side-effects, including hypotension, sedation, dizziness and bradycardia

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence -study information

  • Spinal anaesthesia reduced pain scores compared with epidural anaesthesia, but did not reduce analgesic requirements during 0–24 h or the incidence of PONV Günal et al 2002 Click here for more information
  • Spinal anaesthesia (local anaesthetic) reduced the use of supplementary analgesics and the incidence of nausea compared with general anaesthesia, but data for a reduction in pain scores was inconclusive Tverskoy et al 1990 Click here for more information
  • Spinal anaesthesia (local anaesthetic plus strong opioid) significantly reduced supplementary opioid requirements and the incidence of PONV, compared with general anaesthesia, but there was no significant difference for pain scores or oral analgesic use Song et al 2000 Click here for more information
  • General anaesthesia was similar to epidural or spinal anaesthesia (mixed population) for VAS pain scores during the early postoperative period, at 8 days and at 30 days, for the duration of analgesic requirement but was associated with higher VAS nausea scores (n=407) Nordin et al 2003
  • General anaesthesia plus wound infiltration was superior to spinal anaesthesia for reducing dynamic pain scores, but not resting pain scores, and for increasing the time to first analgesic request Tverskoy et al 1990 Click here for more information
  • For spinal anaesthesia, bupivacaine 7.5 mg significantly reduced the proportion of patients requiring intra-operative fentanyl compared with bupivacaine 6 mg, but there was no significant difference in pain scores, supplementary analgesic requirements or the incidence of PONV Gupta et al 2003 Click here for more information
  • For spinal anaesthesia, local anaesthetic plus clonidine was of significant analgesic benefit compared with local anaesthetic alone during the early postoperative period, but did not reduce the risk of PONV Dobrydnjov et al 2003 Click here for more information
  • For spinal anaesthesia, local anaesthetic plus neostigmine showed significant benefit compared with local anaesthetic alone for reducing pain scores and increasing time to first analgesia  Tan et al 2000 Click here for more information
  • For spinal anaesthesia, neostigmine 50 µg and 100 µg were not significantly different for reducing VAS pain scores over 24 h, for reducing supplementary analgesic requirements, and for increasing the time to first analgesic request (n=40) Tan et al 2000
  • Tetracaine plus neostigmine caused a significantly higher rate of PONV than tetracaine alone (p<0.05) (two arms, n=60) Tan et al 2000
  • Pre- plus intra-operative epidural morphine plus postoperative naloxone did not significantly reduce postoperative analgesic requirements or VAS pain scores at rest at 6, 12, 24 or 48 h compared with placebo (n=36) Aida et al 1999

PROSPECT Recommendations

  • It is recommended (Grade D) that the choice of operative technique for herniorraphy (open versus laparoscopic) should be primarily based on factors other than the management of postoperative pain e.g. operative risk factors of the patient, risk of wound infection, availability of surgical expertise, risk of rare but serious complications, contraindications to general anaesthetic, recurrence rates, and cost
  • Laparoscopic herniorraphy is associated with less postoperative pain than open non-mesh herniorraphy (Grade A), but data are inconclusive for the relative analgesic effects of laparoscopic herniorraphy and open mesh herniorraphy  
  • A recommendation for pain management following laparoscopic herniorraphy cannot be made until further data are available 

Clinical Practice

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - study information

PROSPECT Recommendations

  • Open mesh procedures are recommended in preference to non-mesh procedures because of lower recurrence rates (Grade A); the recommendation cannot be based on the inconclusive acute pain data (Grade A)
  • There is not enough evidence, at this time, to recommend the following for the management of acute or chronic pain: – the plug-and-patch or the Prolene Hernia System® techniques in preference to the Lichtenstein patch technique (Grade D) – one type of mesh in preference to another (Grade D)  – one mesh fixation technique in preference to another (Grade D)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - study information

  • A systematic review reported that open mesh herniorraphy is associated with a 50–75% reduction in the risk of hernia recurrence compared with open non-mesh herniorraphy Grant 2002
  • The Prolene Hernia System® procedure was superior to the Lichtenstein patch procedure for postoperative VAS pain scores at rest on day 0 (p<0.05) but there was no significant difference on days 1–14, or for the duration of requirement for postoperative analgesia (n=206) Kingsnorth et al 2002b
  • Two of three studies showed a significant benefit of the plug-and-patch procedure over the Lichtenstein open mesh procedure for reducing postoperative pain scores, and in all studies there was no significant difference in analgesic use Abu-Own A et al 2000 Click here for more information
  • The Stoppa procedure was not significantly different from the Lichtenstein patch procedure for VAS pain scores at rest on days 1, 2, 7 and 30, or on movement on days 7 and 30 (n=33) Malazgirt et al 2000
  • The smooth polypropylene mesh was superior to the monofile, rigid mesh for reducing VAS pain scores on day 1 and at 2, 4, 8 and 12 weeks (p<0.05), but there was no significant difference at 3 days or at 1 week (n=40) Langenbach et al 2003
  • A lightweight mesh was superior to a conventional mesh for reducing dynamic pain scores at 6 months but there was no significant difference in pain during the early postoperative period Post et al 2004 Click here for more information
  • Fixation by sutures for hernia repair was similar to fixation with staples for postoperative pain and supplementary analgesic requirements Leibl et al 2002 Click here for more information
  • Six out of ten studies showed no significant benefit of open mesh procedures compared with open non-mesh procedures for reducing pain scores Barth et al 1998 Click here for more information
  • Of eight studies that reported supplementary analgesic use, five showed no significant benefit for mesh procedures compared with non-mesh procedures for reducing analgesic requirements Barth et al 1998 Click here for more information

PROSPECT Recommendations

  • Open mesh procedures are recommended in preference to non-mesh procedures because of lower recurrence rates (Grade A); the recommendation cannot be based on the inconclusive acute pain data (Grade A, see Open Mesh Procedure)
  • There is not enough evidence to recommend one non-mesh repair technique in preference to another for the management of acute or chronic pain (Grade D)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence

  • Suture repair and no suture repair were similar for cumulative pain scores during the first week and for analgesic requirements (n=84) Callesen et al 1999
  • Moloney's darn repair was superior to the Shouldice repair for reducing postoperative VAS pain scores at 6, 12 and 24 h (p<0.05) and for reducing postoperative requirement for analgesia on days 1, 2 and 3 (p<0.05) (n=50) Thapar et al 2000
  • A systematic review reported that open non-mesh herniorraphy is associated with a 50–75% increase in the risk of hernia recurrence compared with open mesh herniorraphy Grant 2002

PROSPECT Recommendations

  • Nerve section/cryoanalgesia techniques are not recommended because of a lack of analgesic benefit (Grade A)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Division of the ilioinguinal nerve was of no significant benefit over preservation of the nerve for VAS pain scores at 1 week, 1 or 6 months, 1 year or at telephone follow up (n=813) Picchio et al 2004
  • Cryoanalgesia was of no benefit for reducing VAS pain scores compared with no treatment or sham treatment in two studies (n=36) Khiroya et al 1986

PROSPECT Recommendations

  • Postoperative COX-2-selective inhibitors are recommended based on their analgesic efficacy (grade A)
  • Since pre-/intra-operative local anaesthetic infiltration techniques provide sufficient analgesia in the immediate postoperative period (grade A), COX-2-selective inhibitors can be initiated orally in the early (1-3 hours) postoperative period
  • COX-2-selective inhibitors may be preferred to conventional NSAIDs in the peri-operative setting, in patients who have an increased risk of bleeding, or who are at risk of gastroduodenal ulcer/erosion (grade B)
  • The use of COX-2-selective inhibitors should depend upon assessment of individual patient risks (cardiovascular morbidity, actual or recent gastroduodenal ulcer history, renal function and hepatic function [grade B] or aspirin-sensitive asthma [grade D])

Clinical Practice

  • Rofecoxib has been withdrawn from the market, and marketing of valdecoxib has been suspended in most countries

Transferable Evidence from Other Procedures

  • COX-2-selective inhibitors provide similar postoperative analgesia to conventional NSAIDs Rømsing et al 2004
  • Randomised endoscopic trials in healthy 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 Harris et al 2001
  • Studies in healthy volunteers demonstrated that COX-2-selective inhibitors had no effect on platelet aggregation Greenberg et al 2000
  • 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 Bavbek et al 2004
  • A study to assess the safety of the COX-2-selective inhibitors parecoxib and valdecoxib following noncardiac 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) (in press, Anesthesiology)
  • 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 Nussmeier et al 2005
  • 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 EMEA 2004a
  • 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. Elderly females, with autoimmune disease, and taking other potentially hepatotoxic drugs, may be most susceptible O'Connor et al 2003
  • 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 Cheng et al 2004
  • COX-2-selective inhibitors and conventional NSAIDs may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication Cheng et al 2004
  • Although there is some concern that COX-2-selective inhibitors may impair wound healing, evidence from animal and clinical studies is conflicting Blomme et al 2003

Herniorraphy-Specific Evidence - Study information

  • Oral rofecoxib administered pre- plus postoperatively significantly reduced postoperative pain scores, compared with placebo, at rest at 1 h (p<0.05) but there was no benefit at 30 min or at the time of first analgesic request (n=60) Ma et al 2004
  • Oral rofecoxib administered pre- plus postoperatively significantly reduced requirements for supplementary hydromorphone in the PACU (p<0.05) (n=60) Ma et al 2004
  • Oral rofecoxib administered pre- plus postoperatively did not significantly reduce the incidence of PONV compared with placebo (n=60) Ma et al 2004

PROSPECT Recommendations

  • Postoperative conventional NSAIDs are recommended based on their analgesic efficacy (grade A)
  • Since pre-/intra-operative local anaesthetic infiltration techniques provide sufficient analgesia in the immediate postoperative period (grade A), conventional NSAIDs can be initiated orally in the early (1-3 hours) postoperative period
  • Conventional NSAIDs are not recommended in patients who have an increased risk of bleeding, or who are at risk of gastroduodenal ulcer/erosion (grade B)
  • The use of conventional NSAIDs should depend upon assessment of individual patient risks (bleeding complications, cardiovascular morbidity, actual or recent gastroduodenal ulcer history, aspirin-sensitive asthma, renal function and hepatic function) (grade B)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • Conventional NSAIDs have proven analgesic efficacy in a variety of surgical procedures Barden et al 2004
  • One randomised trial in patients undergoing transurethral prostatectomy showed that diclofenac did not affect total blood loss compared with placebo Bricker et al 1987
  • Randomised endoscopic trials in healthy 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 Harris et al 2001
  • 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 Greer et al 1999
  • 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 Marret et al 2003
  • A randomised trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction Niemi et al 1997
  • 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 Forrest et al 2002
  • Aspirin and conventional NSAIDs can induce asthma attacks in patients with aspirin-exacerbated respiratory disease Stevenson 2004
  • 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. Elderly females, with autoimmune disease, and taking other potentially hepatotoxic drugs, may be most susceptible O'Connor et al 2003
  • 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 Cheng et al 2004
  • Conventional NSAIDs and COX-2-selective inhibitors may elevate blood pressure, particularly in hypertensive patients receiving antihypertensive medication Cheng et al 2004

Herniorraphy-Specific Evidence

  • Lysine acetyl salicylate and morphine were similar for verbal rating pain scores at 0, 0.5, 3, 6, 21 and 27 h, and for the proportion of patients requiring supplementary analgesia, but lysine acetyl salicylate was superior to morphine for reducing the incidence of nausea (p<0.05) (n=30) Cashman et al 1985
  • Lysine clonixinate and paracetamol/codeine were similar for VAS pain scores at rest or on coughing, sitting or applied pressure during the first 2 days, and for supplementary analgesic requirements (n=151) de los Santos et al 1998

PROSPECT Recommendations

  • Gabapentin/pregabalin cannot be recommended at this time (Grade D) due to the lack of procedure-specific evidence, despite analgesic efficacy in other procedures

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • Studies of gabapentin and pregabalin in mastectomy, abdominal surgery, laparoscopic cholecystectomy and spinal surgery showed reductions in postoperative pain and supplementary analgesic requirements for at least 24 h Dahl et al 2004

Herniorraphy-Specific Evidence

  • [None cited]

PROSPECT Recommendations

  • Postoperative ketamine cannot be recommended at this time (Grade D) due to a lack of procedure-specific evidence, and due to associated side-effects that may hinder early ambulation, despite some evidence of analgesic efficacy in other procedures

Clinical Practice

  • Ketamine is associated with a risk of adverse effects on the central nervous system

Transferable Evidence from Other Procedures

  • Studies of ketamine in abdominal, orthopaedic, gastric, hepatic and renal surgery showed a reduction in postoperative pain and opioid use when used as an adjuvant to morphine, either epidurally or intravenously Subramaniam et al 2004

Herniorraphy-Specific Evidence

  • [None cited]

Opioids
Opioids, which can be naturally occurring, semisynthetic or synthetic compounds, produce analgesic effects by binding to opioid receptors in the central nervous system. Several different opioid receptors have been identified and, based on their interactions with these receptors, opioids fall into three main categories:
Pure agonists – drugs that bind to and stimulate opioid receptors, and are capable of producing a maximal response
Partial agonists – drugs that stimulate opioid receptors but have a ceiling effect, i.e. produce a submaximal response compared with an agonist
Mixed agonist-antagonists – drugs that are agonists for one opioid receptor but antagonise other opioid receptors.
Opioids are also classified as being ‘strong’ or ‘weak’, depending on the strength of their clinical effect, which has historically been measured against the effect of morphine.
Some opioids and their classifications are listed below:

Opioid

Agonist property

Clinical ‘strength’

Morphine

Pure

Strong

Oxycodone

Pure

Strong

Hydromorphone

Pure

Strong

Meperidine

Pure

Strong

Fentanyl

Pure

Strong

Methadone

Pure

Strong

Buprenorphine

Mixed

Strong

Nalbuphine

Mixed

Strong

Pentazocine

Mixed

Strong

Meptazinol

Partial

Strong

Tramadol

Partial

Weak

Codeine

Partial

Weak

PROSPECT Recommendations

  • Strong opioids are not recommended for first-line analgesia, despite evidence that they are effective, because of side-effects that may delay early ambulation (Grade D)
  • Strong opioids are recommended as rescue analgesia for severe pain in addition to the use of non-opioid agents (Grade B)

Clinical Practice

  • Strong opioids are not associated with a ceiling effect, and thus can provide effective analgesia for most types of surgical procedures
  • Strong opioids are available in a variety of preparations and routes of administration, enabling choice for onset, duration of action, and mode of delivery

Transferable Evidence from Other Procedures

  • Strong opioids are effective for reducing high- and moderate-intensity postoperative pain McQuay et al 1999
  • Strong opioids are associated with adverse effects, including nausea, vomiting, sedation, confusion, paralytic ileus and urinary retention Wheeler et al 2002

Herniorraphy-Specific Evidence - Study information

  • Postoperative sustained release morphine followed by dihydrocodeine was superior to dihydrocodeine plus paracetamol for reducing pain scores during days 0–5 (p=0.005, n=50) Fenton-Lee et al 1994
  • Postoperative papaveretum/aspirin provided no significant analgesic benefit over placebo, whether both groups received pre-operative inguinal field block or not (n=200) Nehra et al 1995
  • Postoperative papaveretum/aspirin was of no significant benefit over placebo for reducing the incidence of PONV (both groups received rescue opioid) (n=200) Nehra et al 1995
  • Sustained release morphine followed by dihydrocodeine was inferior to dihydrocodeine plus paracetamol for reducing postoperative nausea scores (n=50) Fenton-Lee et al 1994

PROSPECT Recommendations

  • Weak opioids are recommended based on their analgesic efficacy (Grade B), when conventional NSAIDs or COX-2-selective inhibitors plus paracetamol are not sufficient or are contraindicated

Clinical Practice

  • Tramadol is beneficial when conventional NSAIDs are contraindicated
  • The oral solution (drops) is useful as rescue medication when paracetamol/conventional NSAIDs/COX-2-selective inhibitor analgesic regimens are used
  • Tramadol is useful in the treatment of postoperative pain of moderate intensity (intravenous and oral administration), providing effective analgesia in the in-patient and ambulatory setting
  • Opioid adverse effects, especially nausea and dizziness, limit the usefulness of tramadol, but many of the effects are less than for strong opioids

Transferable Evidence from Other Procedures

  • The combination of tramadol and paracetamol enhances analgesic efficacy compared with either agent alone McQuay H et al 2003

Herniorraphy-Specific Evidence - Study information

  • Postoperative dihydrocodeine plus paracetamol was superior to sustained release morphine followed by dihydrocodeine for reducing postoperative nausea scores (n=50) Fenton-Lee et al 1994
  • Codeine plus paracetamol was of no significant benefit over lysine clonixinate for reducing postoperative VAS pain scores at rest or on coughing, sitting or applied pressure during the first 2 days, or supplementary analgesic requirements (n=151) de los Santos et al 1998
  • Dihydrocodeine plus paracetamol was inferior to sustained release morphine for reducing pain scores during days 0–5 (p=0.005, n=50) Fenton-Lee et al 1994

 PROSPECT Recommendations

  • Paracetamol is recommended for routine pain therapy in combination with conventional NSAIDs/COX-2-selective inhibitors or weak opioids based on evidence from other surgical procedures (Grade B)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • Paracetamol is an effective analgesic for the treatment of postoperative pain of moderate intensity Hyllested et al 2002
  • Paracetamol combined with weak opioids (codeine, tramadol) is superior to weak opioids alone in a review of dental, gynaecological and orthopaedic surgery McQuay H et al 2003
  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Postoperative dihydrocodeine plus paracetamol was superior to sustained release morphine followed by dihydrocodeine for reducing postoperative VAS nausea scores (n=50) Fenton-Lee et al 1994
  • Paracetamol plus codeine was of no significant benefit over lysine clonixinate for reducing postoperative VAS pain scores at rest or on coughing, sitting or applied pressure during the first 2 days, or supplementary analgesic requirements (n=151) de los Santos et al 1998
  • Dihydrocodeine plus paracetamol was inferior to sustained release morphine followed by dihydrocodeine for reducing pain scores during days 0–5 (p=0.005, n=50) Fenton-Lee et al 1994

PROSPECT Recommendations

  • Postoperative continuous wound infusion with local anaesthetic cannot be recommended at this time, despite evidence for its analgesic efficacy, because of limited data (Grade D)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence

PROSPECT Recommendations

  • Postoperative single/repeat dose of local anaesthetic by catheter in the wound is not recommended because of a lack of analgesic effect (Grade A)
  • Postoperative subcutaneous infiltration cannot be recommended at this time because of limited data (Grade D)

Clinical Practice

  • [None specified]

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • Pre- plus intra- plus postoperative inguinal nerve block/field block/infiltration was superior to placebo for reducing pain scores on lying, sitting and walking at 8 h and on days 1–5 (p<0.05) but there was no significant difference at 10 or 30 days (n=70) Fischer et al 2000
  • Pre- plus intra- plus postoperative inguinal nerve block/field block/infiltration was superior to placebo for reducing the proportion of patients requiring supplementary ibuprofen at 0 and 2 days (p<0.05) (n=70) Fischer et al 2000
  • Postoperative wound instillation with bupivacaine in repeat doses via a catheter was similar to systemic conventional NSAIDs for reducing pain scores at 0–30 h, and for reducing use of supplementary metamizole (n=104) Zieren et al 1999
  • Postoperative single/repeat bolus of local anaesthetic by a catheter in the wound did not reduce pain scores compared with placebo or no such treatment Cameron et al 1985 Click here for more information
  • Postoperative single/repeat bolus of local anaesthetic by a catheter in the wound was of no benefit for reducing supplementary analgesic requirements compared with placebo or no such treatment (n=101) Cameron et al 1985
  • For postoperative wound instillation, ropivacaine and bupivacaine were similar for postoperative VAS pain scores at rest and on movement on days 0 and 1, for supplementary analgesic requirements, and for the incidence of PONV (n=51) Vintar et al 2002

PROSPECT Recommendations

  • Subfascial infiltration with local anaesthetics cannot be recommended in preference to subcutaneous infiltration at this time because of limited data (Grade D)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  •  [None cited]

Herniorraphy-Specific Evidence - Study information

  • Subfascial local anaesthetic showed a significant benefit over subcutaneous local anaesthetic for reducing pain scores during the first postoperative hour, but there was no difference in supplementary analgesic requirements Yndgaard et al 1994 Click here for more information

PROSPECT Recommendations

  • TENS is not recommended because of a lack of analgesic benefit (Grade A)

Clinical Practice

  • [None cited]

Transferable Evidence from Other Procedures

  • [None cited]

Herniorraphy-Specific Evidence - Study information

  • TENS was of no benefit compared with sham TENS for reducing VAS pain scores on days 1, 2 and 3 (n=40) Gilbert et al 1986
  • TENS was of no benefit compared with sham TENS for reducing postoperative analgesic requirements (n=40) Gilbert et al 1986