The review of this procedure will take place in 2019 and will be published by end of 2021
Knowledge Key:
Arguments against Arguments againste
Arguments for Arguments for
Prospect Recommendation Prospect Recommendation
Clinical Practice Clinical Practice
Transferable Evidence Transferable Evidence
Procedure Specific Evidence Procedure Specific Evidence

Pre-Operative

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Systemic Analgesia

PROSPECT Recommendations

  • As with all analgesics, COX-2-selective inhibitors should be administered at the appropriate time (pre- or intra-operatively) to provide sufficient analgesia in the early recovery period (GoR B), based on transferable evidence from diverse procedures showing analgesic efficacy (LoE 1)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • Rofecoxib and valdecoxib have been withdrawn from the market
  • 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

Transferable Evidence

  • Intravenous parecoxib (40 mg bid for 3 days) followed by oral celecoxib (0.2 g bid for 4 days) was as effective as intravenous tramadol (0.1 g tid for 3 days) with continued oral tramadol (0.1 g tid for 4 days) for reducing pain intensity during leg raising from the fourth day after major abdominal surgery in a randomised study (n=112) Xu et al 2013 Click here for more information
  • A retrospective cohort study showed that the COX-2-selective inhibitors rofecoxib and celecoxib were associated with a lower risk of acute kidney infection than less-selective NSAIDs Lafrance and Miller 2009
  • A meta-analysis that included data from 17 parecoxib and 15 valdecoxib placebo-controlled trials in non-cardiac surgery showed that there was no significant association between short-term treatment with parecoxib and/or valdecoxib and an increase in cardiovascular thromboembolic adverse events, compared with placebo (n=8511 overall) Schug et al 2009
  • A review concluded that COX-2-selective inhibitors were as effective as conventional NSAIDs for treatment of postoperative pain in various surgical models, and offer a number of other advantages including: reduced incidence of gastrointestinal ulceration, no inhibitory effect on platelet function (and thereby a reduced risk of blood loss) and no induction of bronchospasm in patients with aspirin-sensitive asthma Schug 2006
  • 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) Nussmeier et al 2006
  • 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 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
  • Studies in healthy volunteers demonstrated that COX-2-selective inhibitors had no effect on platelet aggregation compared with placebo Noveck et al 2001
  • 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
  • A systematic review including sixty studies of major surgery concluded that compared with placebo, COX-2-selective inhibitors provide similar reduction in 24-hour PCA morphine consumption to conventional NSAIDs and paracetamol Maund et al 2011
  • COX-2-selective inhibitors provide similar postoperative analgesia to conventional NSAIDs Rømsing et al 2004
  • In a randomized, double-blind study in ambulatory surgery, ibuprofen (1200 mg/day) and celecoxib (400 mg/day) significantly decreased the need for rescue analgesic medication after discharge, improved the quality of recovery scores and patient satisfaction with postoperative pain management, and decreased the incidence of postoperative constipation vs placebo (p<0.05 for all comparisons) White et al 2011
  • A systematic review including eight randomised studies concluded that single-dose oral celecoxib is an effective analgesic for postoperative pain relief Derry and Moore 2012
  • 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 Møiniche et al 2002
  • Two clinical trials showed that in patients who had undergone coronary artery bypass graft 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 Harris 2002
  • Although there is some concern COX-2-selective inhibitors may impair wound healing, evidence from animal and clinical studies is conflicting Blomme et al 2003

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Pre-operative dexamethasone is recommended both for its analgesic and anti-emetic effects (GoR B), based on transferable evidence from multiple procedures (LoE 1), despite lack of procedure-specific evidence
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • A systematic review including forty-five studies (n= 5796) concluded that a single IV perioperative dose of dexamethasone had small but statistically significant analgesic benefits vs placebo or anti-emetic (reduced pain scores at 2 and 24 hours, reduced opioid use, increased time to first analgesic, and reduced duration of PACU stay) Waldron et al 2013
  • A meta-analysis of twenty-four studies including 2751 subjects concluded that dexamethasone at doses >0.1 mg/kg is effective as a part of multimodal pain management for reduction of postoperative pain at rest and movement and reduction of opioid consumption after surgery. Pre-operative administration of dexamethasone appeared to produce a more consistent analgesic effect vs intraoperative administration Waldron et al 2013
  • A single prophylactic dose of corticosteroid is effective for preventing PONV in surgery associated with high emetic effects Henzi et al 2000
  • A review of major abdominal surgery, a randomised study of patients at high-risk of nausea and vomiting undergoing surgery, and a systematic review of drugs that prevent PONV, all showed that corticosteroids decrease PONV Apfel et al 2004

Radical Prostatectomy-Specific Evidence

  • None cited

PROSPECT Recommendations

  • Pre-operative gabapentinoids are recommended (GoR B) based on transferable evidence from multiple procedures showing analgesic efficacy (LoE 1), despite lack of procedure-specific evidence
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • Four systematic reviews and three meta-analyses evaluated the use of gabapentinoids for postoperative analgesia and demonstrated significant reductions in postoperative pain and/or supplementary analgesic requirements compared with inactive controls Ho et al 2006
  • Two systematic reviews and two meta-analyses showed a significant reduction in the incidence of nausea and/or vomiting with gabapentin compared with inactive controls, although a meta-analysis and a systematic review of studies of pre-operative gabapentin, showed no significant difference in the incidence of side-effects Ho et al 2006
  • Two systematic reviews showed a significant increase in the incidence of sedation with gabapentin compared with inactive controls, and one meta-analysis found a non-significant increase in risk of sedation with gabapentin, although found no significant difference between pregabalin and placebo/control Peng et al 2007
  • One systematic review found a significant increase in the risk of visual disturbance with pregabalin and one meta-analysis found a significant increase in dizziness with gabapentin compared with placebo/control Peng et al 2007

Radical Prostatectomy-Specific Evidence

  • None cited

PROSPECT Recommendations

  • Belladonna and opium suppository (and melatonin, amantadine and clonidine) are not recommended (GoR D) due to limited procedure-specific evidence
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • None cited

Radical Prostatectomy-Specific Evidence