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

Radical Prostatectomy 2012

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Summary Recommendations

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Notes on PROSPECT recommendations

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. Grades of recommendation (GoR) are assigned according to the overall level of evidence (LoE) on which the recommendations are based, which is determined by the quality and source of evidence.

Summary table: Grades of recommendation (GoR) based on source and level of evidence (LoE)

 
Study type LoE GoR (based on overall LoE, considering balance of clinical practice information and evidence)
Procedure-specific Transferable
Systematic review with homogeneous results 1 A B
Randomised controlled trial (RCT) – high quality 1

A

(based on two or more studies or a single large, well-designed study)

 B
RCT – with limitations in methodology or reporting 2

B

(or extrapolation from one procedure-specific LoE 1 study)

 C
Non-systematic review, cohort study, case study; (e.g. some adverse effects evidence) 3 C
Clinical practice information (expert opinion); inconsistent evidence 4

D

An explanation of how study quality assessments are performed to determine the LoE and GoR can be found in Radical Prostatectomy: Evidence Review Process. The AGREE II instrument (Brouwers 2010) is used internationally to assess the methodological rigour and transparency of practice guidelines. As far as possible, the methodology of the PROSPECT Radical Prostatectomy review meets the requirements of ‘Domain 3: Rigour of development’ of the AGREE II instrument:
  • Systematic methods were used to search for evidence.
  • The criteria for selecting the evidence are clearly described.
  • The strengths and limitations of the body of evidence are clearly described.
  • The methods for formulating the recommendations are clearly described.
  • The health benefits, side effects, and risks have been considered in formulating the recommendations.
  • There is an explicit link between the recommendations and the supporting evidence.
  • The guideline has been externally reviewed by experts prior to its publication. [The evidence and recommendations will be submitted for peer-review after publication on the PROSPECT website]
  • A procedure for updating the guideline is provided. [Methodology is provided so that the systematic review can be updated as required]
 

Interventions that are recommended for radical prostatectomy

Pre-operative interventions that are recommended for radical prostatectomy

Note: Unless otherwise stated, ‘pre-operative’ refers to interventions applied before surgical incision

Note: All analgesics should be administered at the appropriate time
(pre- or intra-operatively) to provide sufficient analgesia in the early recovery period

COX-2-selective inhibitors

·         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)

Dexamethasone

·         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

Gabapentinoids

·         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

Intra-operative interventions that are recommended for radical prostatectomy

Note:

- Unless otherwise stated, ‘intra-operative’ refers to interventions applied after incision and before wound closure

- All analgesics should be administered at the appropriate time
(pre- or intra-operatively) to provide sufficient analgesia in the early recovery period

- All intra-operative anaesthetic and/or analgesic interventions are considered in the postoperative section.

Postoperative interventions that are recommended for radical prostatectomy

Note: ‘Postoperative’ refers to interventions applied at or after wound closure

COX-2-selective inhibitors

·         COX-2-selective inhibitors are recommended (GoR B) based on transferable evidence from multiple procedures showing analgesic efficacy (LoE 1), despite a lack of procedure-specific evidence

Systemic lidocaine

·         Lidocaine infusion is recommended for radical prostatectomy (GoR B), due to transferable evidence from multiple procedures showing analgesic efficacy (LoE 1) despite limited procedure-specific evidence

Systemic strong opioids

·         Systemic strong opioids are recommended following prostatectomy (GoR B), based on transferable evidence from multiple procedures, for their efficacy in reducing high-intensity postoperative pain (VAS >/=50 mm) (LoE 1), with the following considerations:

·         Systemic strong opioids should be used in combination with COX-2-selective inhibitors and paracetamol to reduce opioid use and its associated side-effects (GoR D)

·         IV PCA strong opioids are recommended (GoR B) based on greater patient satisfaction compared with regular (fixed-interval) or PRN dosing (transferable evidence, LoE 1); however, fixed-interval IV administration titrated to pain intensity is also recognised as an effective mode of administration (LoE 4)

Systemic weak opioids

·         Weak opioids are recommended to be used for moderate- or low-intensity pain if non-opioid analgesia is insufficient or is contra-indicated (GoR B), based on transferable evidence (LoE 1) showing analgesic efficacy in multiple surgical procedures

·         Weak opioids are recommended to be used in combination with non-opioid analgesics (GoR B), based on transferable evidence (LoE 1) showing analgesic efficacy in combination regimens

Paracetamol

·         Paracetamol is recommended (GoR B) due to strong transferable evidence from multiple procedures showing analgesic efficacy (LoE 1) despite lack of procedure-specific evidence

·         Paracetamol should be administered at the appropriate time (pre- or intraoperatively) to provide sufficient analgesia in the early recovery period (GoR D)

Alternative analgesics

·         Muscarinic receptor antagonists (oxybutynin, tolterodine) are recommended (GoR B) to prevent bladder discomfort based on procedure-specific (LoE 1) and transferable evidence from various procedures (LoE 2)

Wound infiltration or infusion

·         For open prostatectomy local anaesthetic wound infiltration administered at the end of surgery is recommended (GoR B) because transferable evidence from hernia repair shows analgesic efficacy (LoE1) and because it is a convenient technique with a favourable safety profile, despite limited procedure-specific evidence

·         For video-assisted prostatectomy local anaesthetic port-site infiltration administered at the end of surgery is recommended (GoR B) because transferable evidence from laparoscopic cholecystectomy shows analgesic efficacy (LoE 1) despite lack of procedure-specific evidence

·         Long-acting local anaesthetics are recommended in preference to short-acting local anaesthetics (GoR D)

 

Interventions that are NOT recommended for radical prostatectomy

Alternative analgesics: Pre-operative belladonna and opium suppository, melatonin, amantadine, or clonidine

Not recommended (GoR D) due to limited procedure-specific evidence

Intra- and postoperative conventional NSAIDs

Not recommended (GoR B) based on limited procedure-specific (LoE 2) and strong transferable evidence from multiple procedures concerning an increased risk of bleeding (LoE 1)

Intra- or postoperative ketamine

Not recommended for routine use (GoR D) because of conflicting procedure-specific evidence (LoE 4), despite favourable transferable evidence from more painful surgical procedures (LoE 1)

Lidocaine patch

Not recommended (GoR B) based on limited procedure-specific evidence

IM strong opioids

Not recommended because of the pain associated with these injections (GoR D)

Transdermal nicotine and intravenous magnesium

Not recommended (GoR D) due to limited procedure-specific and transferable evidence

Epidural analgesia

Not recommended for prostatectomy (GoR D) despite some procedure-specific evidence (LoE 1) of analgesic benefit, due to adverse risk:benefit profile

Paravertebral analgesia

Not recommended (GoR D) due to limited procedure-specific evidence

TAP-blocks

Not recommended (GoR D) due to lack of procedure-specific and limited transferable evidence

Intrathecal opioid anaesthesia and analgesia

Not recommended (GoR B) despite procedure-specific evidence (LoE 1) of analgesic benefit, due to adverse risk:benefit profile (intrathecal anaesthesia is also not recommended). This statement is supported by transferable evidence (LoE 1) from patients undergoing major surgery

Continuous local anaesthetic wound infusion

Not recommended (GoR B) based on procedure-specific evidence (LoE 2) showing lack of analgesic efficacy

Magnesium sulfate wound infiltration

Not recommended (GoR D) due to limited procedure-specific evidence


Evidence Review Process

PROSPECT Radical Prostatectomy Subgroup and Working Group process

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.

For the Radical Prostatectomy review, the Subgroup members were:
  • Professor Girish Joshi (PROSPECT Working Group member)
  • Professor Francis Bonnet (PROSPECT Working Group member)
Dr Thomas Jaschinski (IFOM - Institut für Forschung in der Operativen Medizin, Universität Witten/Herdecke, Köln, Germany) provided support in conducting the literature search, preparing the evidence summary and coordinating the Subgroup and Working Group reviews of the evidence to prepare the final recommendations.

The recommendations for postoperative pain management in Radical Prostatectomy were voted on by eight Working Group members to show the strength of consensus. The results of each vote are indicated within the PROSPECT recommendations sub-folders.

Literature search


Radical Prostatectomy: Sources and levels of evidence (LoE) determine the grades of recommendation (GoR)

Sources of evidence in PROSPECT

The evidence for prospect is derived from three separate sources, and this evidence is taken into consideration by the prospect Working Group to determine the prospect recommendations:
  • Procedure-specific evidence derived from the systematic reviews of the literature
  • Transferable evidence from comparable procedures, or from other relevant sources, identified by the members of the prospect Working Group
  • Current practice – A commentary on the interventions from the members of the prospect Working Group
  • Practical prospect recommendations are based on all the information

Study quality assessment

For the Radical Prostatectomy review, the quality of procedure-specific evidence has been assessed according to NICE methodology, to determine the possibility of selection bias, performance bias, attrition bias and detection bias (www.nice.org.uk/media/615/64/The_guidelines_manual_2009.pdf).

Any limitations in the reporting of cited procedure-specific studies are described in the evidence tables within each Procedure-Specific Evidence folder.

GoR are assigned according to the overall LoE, which is determined by the quality of studies cited, the consistency of evidence and the source of evidence (as indicated in the Table below).

Quality indicators used to determine the LoE of individual studies:
  • Allocation concealment: indicates whether there was adequate prevention of foreknowledge of treatment assignment by those involved in recruitment (in the table below, A=adequate, B=unclear, C=inadequate, D=not used). Empirical research has shown that trials with inadequate or unclear allocation concealment report significantly greater estimates of treatment effect than those trials in which concealment was adequate (Chalmers 1983, Schulz 1995, Moher 1998). Allocation concealment was found to be more important for preventing bias than other aspects of study quality, such as generation of the allocation sequence and double-blinding (Chalmers 1983, Schulz 1995, Moher 1998, HigginsandGreen 2005: Section 6.3. http://www.cochrane.org/resources/handbook/hbook.htm)
  • Statistical analyses and patient follow-up: indicates whether statistical analyses were reported, and whether patient follow-up was greater or less than 80%.
  • Numerical scores (total 1–5) for study quality: assigned using the method proposed by Jadad 1996, to indicate whether a study reports appropriate randomisation, double-blinding and statements of possible withdrawals. Empirical research found that low-quality trials were associated with an increased estimate of treatment benefit than high-quality trials (Moher 1998)

Table: Relationship between quality and source of evidence, levels of evidence and grades of recommendation in PROSPECT

 

 

Study quality assessments

Level of Evidence (LoE)

Grade of recommendation
(based on overall LoE, considering balance of clinical practice information and evidence)
Study type

Statistical analyses and patient follow-up assessment

 

Allocation concealment

Jadad scores

Additional assessment of overall study quality required to judge LoE

 

Procedure-specific

Transferable

Systematic review with homogeneous results

N/A

 

N/A

N/A

N/A

1

A

B

Randomised controlled trial (RCT)

Statistics reported
and >80%
follow-up

AND

A

(1-5)

N/A

1

A

(based on two or more studies or a single large, well-designed study)

B

OR

B

(3-5)

N/A

OR

B

(1-2)

Yes

RCT

Statistics not reported or questionable or <80% follow-up

AND/OR

B

(1-2)

Yes

2

B

(or extrapolation from one procedure-specific
LoE 1 study)

C

OR

C

(1-5)

N/A

OR

D

(1-5)

N/A

Non-systematic review, cohort study,
case study;

 (e.g. some adverse effects evidence)

N/A

 

N/A

3

C

Clinical practice information (expert opinion); inconsistent evidence

N/A

 

N/A

4

D

 



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 has been included to support the procedure-specific evidence where this is insufficient to formulate the recommendations.

Transferable evidence includes evidence of analgesic efficacy from a variety of procedures that have some similarity to radical prostatectomy in terms of pain pathology, including abdominal surgery, laparoscopic colonic resection, laparoscopic cholecystectomy, open or laparoscopic hysterectomy, herniorraphy, percutaneous nephrolithotomy surgery and urologic surgery. Systematic reviews of pain management for multiple surgical procedures are also cited.

Transferable evidence of other outcomes, such as adverse effects, is included from a variety of surgical procedures.

Topics for Future Research

Topics for future research

Many of the studies included in this systematic review of postoperative pain management in radical prostatectomy have methodological shortcomings. Therefore, further high-quality randomised clinical trials are required.

Abbreviations

List of abbreviations

 

BMI

body mass index

CCT

clinical controlled trial

CG

control group

E-LRPE

extraperitoneal laparoscopic radical prostatectomy

GA

general anesthesia

IG

intervention group

ITT

intention to treat (statistical method for analysis)

i.t.

intrathecal

i.m. or IM

intramuscular

i.v. or IV

intravenous

IQR

interquartile range

LRP

laparoscopic radical prostatectomy

LOS

length of stay

LN-SV-TPP

laparoscopic pelvic lymph node dissection (PLND), laparoscopically assisted seminal vesicle mobilization, and total perineal prostatectomy

n

absolute value

NPS

numeric pain score

O-RPE

open extraperitoneal radical prostatectomy

PACU

post-anesthesia care unit

PCA

patient controlled analgesia

PCEA

patient-controlled epidural analgesia

POD

postoperative day

PONV

postoperative nausea and vomiting

POSAS

patient and observer scar assessment scale

p.o.

per os

PRN

pro re nata (as needed)

QoL

quality of life

RALRP

robot-assisted laparoscopic radical prostatectomy

RCT

randomised controlled trial

rg

range

RRP

radical retropubic prostatectomy

SD

standard deviation

SEM

standard error of mean

SpA

spinal anesthesia

TAP block

transversus abdominis plane block

TEA

thoracic epidural analgesia

TRUS

transrectal prostatic ultrasound

T-LRPE

transperitoneal laparoscopic radical prostatectomy

VAS

visual analogue scale

VIP

Vattikuti Institute prostatectomy

VNS

verbal numeric scale

VRS

verbal rating scale

yr.

years

Pre-Operative

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

Intra-Operative

PROSPECT Recommendations

  • No recommendation can be made at the present time regarding particular surgical techniques, due to limited procedure-specific evidence
  • It is recommended that surgical requirement rather than pain management should be the main consideration in choosing the surgical procedure (GoR D)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • None cited

Radical Prostatectomy-Specific Evidence

Postoperative

PROSPECT Recommendations

  • COX-2-selective inhibitors are recommended (GoR B) based on transferable evidence from multiple procedures showing analgesic efficacy (LoE 1), despite a lack of procedure-specific evidence
  • 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
  • Studies in healthy volunteers demonstrated that COX-2-selective inhibitors had no effect on platelet aggregation Greenberg et al 2000
  • 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 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 Cheng et al 2004
  • 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

  • None cited

PROSPECT Recommendations

  • Intra- and postoperative conventional NSAIDs are not recommended (GoR B) based on limited procedure-specific (LoE 2) and strong transferable evidence from multiple procedures concerning an increased risk of bleeding (LoE 1)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • The use of conventional NSAIDs should depend upon assessment of individual patient risks, including bleeding complications, actual or recent gastroduodenal ulcer history, cardiovascular morbidity, aspirin-sensitive asthma, renal function and hepatic function

Transferable Evidence

  • A systematic review including sixty studies of major surgery concluded that compared with placebo, conventional NSAIDs provide similar reduction in 24-hour PCA morphine consumption to COX-2-selective inhibitors and paracetamol Maund et al 2011
  • 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 Marret et al 2005
  • In laparoscopic colonic resection, postoperative IV ketorolac was superior to placebo for reduction of: VAS pain scores during walking on Days 1 (p<0.001), 2 (p<0.05) and 3 (p<0.001), but not on Day 4; postoperative PCA morphine requirement (p=0.011); time to first flatus (p=0.005); and time to return to full diet (p=0.033) (n=44) Schlachta et al 2007 Click here for more information
  • Conventional NSAIDs were superior to placebo for reducing morphine consumption in abdominal hysterectomy but did not consistently reduce pain scores in two studies (PROSPECT systematic review) Ng et al 2002a Click here for more information
  • One randomised trial in patients undergoing transurethral prostatectomy showed that diclofenac did not affect total blood loss compared with placebo Bricker et al 1987
  • Conventional NSAIDs have proven analgesic efficacy in a variety of surgical procedures Barden 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
  • 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 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
  • Aspirin and conventional NSAIDs can induce asthma attacks in patients with aspirin-exacerbated respiratory disease Stevenson 2004
  • 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 trial in healthy volunteers showed that three conventional NSAIDs (diclofenac, ketorolac and ketoprofen) caused a reversible platelet dysfunction Niemi et al 1997
  • 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
  • Conventional NSAIDs were associated with a significant increase in the risk of surgical bleeding and severe surgical bleeding compared with placebo in a meta-analysis of randomised trials in a variety of surgical procedures (nine trials reporting on surgical bleeding complications) Elia et al 2005
  • A systematic review identified six studies comparing conventional NSAIDs with placebo in major surgery that reported on surgical bleeding, and found that overall 2.4% of patients receiving conventional NSAIDs experienced surgical-related bleeding compared with 0.4% receiving placebo Maund et al 2011
  • 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
  • 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
  • Conventional NSAIDs and placebo were not significantly different for the incidence of PONV (all groups received background strong opioid) in patients undergoing abdominal surgery Blackburn et al 1995 Click here for more information

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Intra- or postoperative ketamine is not recommended for routine use (GoR D) because of conflicting procedure-specific evidence (LoE 4), despite favourable transferable evidence from more painful surgical procedures (LoE 1)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • Studies of intravenous or neuraxial ketamine in a variety of surgeries, including abdominal, gynaecological, orthopaedic, gastric, hepatic, and genitourinary surgery, showed a reduction in postoperative pain and opioid use when used as an adjunct to morphine Laskowski et al 2011
  • A systematic review found that intravenous ketamine was associated with analgesic benefit particularly in painful procedures, including upper abdominal, thoracic, and major orthopedic surgeries Laskowski et al 2011
  • Low-dose ketamine was associated with few and mild adverse effects, especially when administered in conjunction with general anaesthesia Bell et al 2006

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Lidocaine patch is not recommended (GoR B) based on limited procedure-specific evidence
  • Lidocaine infusion is recommended for radical prostatectomy (GoR B), due to transferable evidence from multiple procedures showing analgesic efficacy (LoE 1) despite limited procedure-specific evidence
  • Voting for: 7; voting against: 1; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • A meta-analysis of randomised clinical trials performed to evaluate the effect of continuous IV lidocaine infusion during and after abdominal surgery, reported that lidocaine significantly reduced postoperative VAS pain scores, duration of postoperative ileus, incidence of PONV and length of hospital stay, compared with the controls Marret et al 2008
  • In laparoscopic colonic resection, continuous intra-/postoperative IV lidocaine was superior to placebo for reducing: postoperative pain scores; opioid consumption; time to first flatus and first bowel movement; and length of hospital stay (n=40) Kaba et al 2007 Click here for more information
  • A meta-analysis concluded that systemic lidocaine may be a useful adjunct for postoperative analgesia after abdominal surgery, associated with decreased postoperative pain intensity and opioid consumption, improved GI function, and shortened hospital stay compared with controls Sun et al 2012

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Systemic strong opioids are recommended following prostatectomy (GoR B), based on transferable evidence from multiple procedures, for their efficacy in reducing high-intensity postoperative pain (VAS >/=50 mm) (LoE 1), with the following considerations:
  • Systemic strong opioids should be used in combination with COX-2-selective inhibitors and paracetamol to reduce opioid use and its associated side-effects (GoR D)
  • IV PCA strong opioids are recommended (GoR B) based on greater patient satisfaction compared with regular (fixed-interval) or PRN dosing (transferable evidence, LoE 1); however, fixed-interval IV administration titrated to pain intensity is also recognised as an effective mode of administration (LoE 4)
  • IM strong opioids are not recommended because of the pain associated with these injections (GoR D)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • Strong opioids are effective for reducing high- and moderate-intensity postoperative pain McQuay et al 1999
  • Opioids administered by PCA improved analgesia, decreased the risk of pulmonary complications and patients preferred them compared with regular IM, IV or SC opioid treatment, as determined in a quantitative systematic review of randomised trials in various surgical procedures Walder et al 2001
  • Strong opioids are associated with adverse effects, including nausea, vomiting, sedation, confusion, paralytic ileus and urinary retention Wheeler M et all 2002

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Weak opioids are recommended to be used for moderate- or low-intensity pain if non-opioid analgesia is insufficient or is contra-indicated (GoR B), based on transferable evidence (LoE 1) showing analgesic efficacy in multiple surgical procedures
  • Weak opioids are recommended to be used in combination with non-opioid analgesics (GoR B), based on transferable evidence (LoE 1) showing analgesic efficacy in combination regimens

Clinical Practice

  • Dextropropoxyphene has been withdrawn from several markets due to concern regarding its adverse events profile

Transferable Evidence

  • Tramadol was more effective than placebo for pain relief in a meta-analysis of post-surgical patients Moore et al 1997
  • The combination of tramadol and paracetamol enhances analgesic efficacy compared with either agent alone McQuay H et al 2003
  • A systematic review found that the combination of dextropropoxyphene 65 mg with paracetamol 650 mg showed similar efficacy to tramadol 100 mg but with a lower incidence of adverse effects Collins et al 2000
  • A systematic review found that the combination of codeine with paracetamol provided additional pain relief compared with paracetamol alone Moore et al 2000
  • Adverse effects associated with tramadol include headache, nausea, vomiting, dizziness, 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 Moore et al 1997
  • A systematic review found that the combination of codeine with paracetamol was associated with an increase in drowsiness and dizziness compared with paracetamol alone Moore et al 2000
  • A systematic review found an increased incidence of central nervous system adverse effects with paracetamol plus dextropropoxyphene compared with placebo Collins et al 2000

Radical Prostatectomy-Specific Evidence

  • None cited

PROSPECT Recommendations

  • Paracetamol is recommended (GoR B) due to strong transferable evidence from multiple procedures showing analgesic efficacy (LoE 1) despite lack of procedure-specific evidence
  • Paracetamol should be administered at the appropriate time (pre- or intraoperatively) to provide sufficient analgesia in the early recovery period (GoR D)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • Paracetamol is an effective analgesic for the treatment of postoperative pain of moderate intensity Rømsing et al 2002
  • A systematic review including sixty studies of major surgery concluded that compared with placebo, paracetamol provides similar reduction in 24-hour PCA morphine consumption to COX-2-selective inhibitors and conventional NSAIDs Maund et al 2011
  • 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
  • A meta-analysis of randomised controlled trials showed that paracetamol combined with PCA morphine induced a significant morphine-sparing effect but did not change the incidence of morphine-related adverse effects in the postoperative period Remy 2005
  • 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 Altman 2004
  • In a systematic review, paracetamol plus NSAID conferred no significant benefit over NSAID alone for reducing pain scores in orthopaedic and gynaecological operations. However, a significant benefit was seen in the lower-intensity pain associated with dental operations Rømsing et al 2002

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Transdermal nicotine and intravenous magnesium are not recommended (GoR D) due to limited procedure-specific and transferable evidence
  • Muscarinic receptor antagonists (oxybutynin, tolterodine) are recommended (GoR B) to prevent bladder discomfort based on procedure-specific (LoE 1) and transferable evidence from various procedures (LoE 2)
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • Pre-treatment with either 5 mg oxybutynin or 2 mg tolterodine compared with placebo in patients undergoing percutaneous nephrolithotomy surgery reduced the incidence and severity of catheter-related bladder discomfort (p<0.05) (N=234; Agarwal 2006) Agarwal et al 2006
  • The administration of 2 mg tolterodine compared with placebo in patients undergoing urologic surgery was superior in reducing the incidence and severity of catheter-related bladder discomfort (p<0.05) (N=215; Agarwal 2005) Agarwal et al 2005
  • The administration of 10 mg oxybutynin or 200 mg phenazopyridine compared with placebo in patients who received a unilateral stent after ureteroscopy showed no significant difference in bothersome score among the groups for flank pain, suprapubic pain, urinary frequency, urgency, and dysuria (N=52; Norris 2008) Norris et al 2008
  • Two systematic reviews of randomised controlled trials comparing magnesium with placebo demonstrated inconclusive results overall with regards to pain scores and supplemental analgesic use Lysakowski 2007

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Epidural analgesia is not recommended for prostatectomy (GoR D) despite some procedure-specific evidence (LoE 1) of analgesic benefit, due to adverse risk:benefit profile
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • Epidural analgesia is associated with a relatively high degree of patient monitoring and rare major complications

Transferable Evidence

  • In a quantitative meta-analysis of studies in abdominal hysterectomy, epidural analgesia had a statistically significant, and marginally clinically significant, benefit over systemic analgesia for reducing postoperative pain scores at 4 h (PROSPECT systematic review) Hindsholm et al 1993 Click here for more information
  • In abdominal hysterectomy, epidural analgesia provided a significant benefit over IV administration for reducing analgesic consumption over 24 h (PROSPECT systematic review) Eriksson-Mjoberg et al 1997b Click here for more information
  • In abdominal hysterectomy, epidural analgesia was associated with a significantly lower incidence of PONV compared with systemic analgesia(PROSPECT systematic review) Camu et al 1991 Click here for more information
  • In laparoscopic cholecystectomy, epidural LA + strong opioid significantly reduced VAS pain scores at 24 h compared with placebo (p<0.05), but there were no differences between groups at 48 h; epidural LA + strong opioid significantly reduced analgesic use compared with placebo (50 mg indomethacin was given rectally, on request) at 0–24 h (p<0.05), but not at 24–48 h Fujii et al 1998
  • A study in laparoscopic cholecystectomy that compared postoperative epidural LA + strong opioid with placebo showed that the incidence of nausea and vomiting was similar in both groups Fujii et al 1998
  • A meta-analysis of randomised controlled trials found that both continuous epidural infusion and PCEA analgesia provided superior postoperative analgesia compared with intravenous PCA analgesia Wu et al 2005
  • Epidural analgesia using local anaesthetic was superior to systemic strong opioid for reducing postoperative pain scores in six studies identified in a systematic review of abdominal surgery Jorgensen et al 2000b
  • Epidural analgesia using a combination of local anaesthetic and strong opioid was superior to local anaesthetic alone for reducing postoperative pain – 15 mm reduction in VAS score on a 100-mm scale – in a meta-analysis of five studies in abdominal surgery Jorgensen et al 2000b
  • Epidural analgesia using local anaesthetics was superior to epidural opioids or systemic opioids for reducing the incidence of postoperative gastrointestinal paralysis, in a systematic review in abdominal surgery Jorgensen et al 2000b
  • Epidural administration of strong opioids is associated with side-effects including pruritis, PONV, urinary retention, and respiratory depression Chaney 1995

Radical Prostatectomy-Specific Evidence

  • The epidural administration of 1 mg/ml ropivacaine, 2 µg/ml fentanyl and 2 µg/ml adrenaline at 10 ml/h for 48 hours compared with placebo was superior in pain reduction for the first 24 postoperative hours but patients in the intervention group more frequently required antiemetics (p<0.05), in RRP Gupta et al 2006 Click here for more information
  • The epidural administration of ropivacaine and fentanyl (5 ml bolus consisting of 0.2% ropivacaine and 1 µg/kg fentanyl; continuous infusion of same solution) was superior to morphine i.v. (initial bolus of 3-5 mg; intravenous continuous infusion, max 40 mg/day) in reducing pain on movement for the first 72 postoperative hours and for pain at rest for the first 6 postoperative hours in RRP Maestroni et al 2007 Click here for more information
  • Epidural PCA (0.15% ropivacaine and 10 µg/ml fentanyl) significantly reduced dynamic pain but not pain at rest compared with intravenous PCA (10 µg/ml fentanyl), in RALRP Hong et al 2009 Click here for more information
  • Patients who received epidural fentanyl or bupivacaine prior to surgical incision (preemptive analgesia) experienced 33% less pain when compared with patients in the control group (postoperative epidural analgesia only) for POD 1 to POD 4 (p=0.007) in RRP Gottschalk et al 1998 Click here for more information
  • Peri-operative epidural analgesia reduced pain scores, analgesic requirements, and blood loss compared with postoperative epidural analgesia. However, epidural administration of 1 µg/ml sufentanil (in addition to 0.3% ropivacaine) during surgery was not superior to administration of 0.3% ropivacaine alone for pain reduction in RRP Hong et al 2011 Click here for more information
  • Epidural administration of 1 mg/ml ropivacaine, 2 µg/ml fentanyl and 2 µg/ml epinephrine at a constant rate of 10 ml/h for 48 hours was superior to 10 ml of ropivacaine 2 mg/ml via intra-abdominal catheter for 48 hours in reducing pain at the incision site at 4-24 hours and in deep pain and pain on coughing at 4-48 hours, in RRP Fant et al 2011 Click here for more information
  • Epidural administration of 20 ml bupivacaine 0.125% and continuous infusion of 8 ml/h (option 1) or 20 mg tramadol with 20 ml bupivacaine 0.125% and infusion of 1 mg/ml tramadol in 20 ml bupivacaine 0.125% combination with a rate of 8 ml/h (option 2) compared with 20 mg tramadol with a continuous infusion of 1 mg/ml tramadol at a rate of 8 ml/h (option 3) showed significantly better results in reducing pain at 12 and 24 hours Aribogan et al 2003 Click here for more information
  • The comparison of epidural with intravenous PCA hydromorphone showed no significant differences in pain at rest and after coughing or in PONV, in RRP Liu et al 1995 Click here for more information
  • The comparison between epidural anaesthesia with ropivacaine, paracetamol, injected morphine or oral dextropropoxyphene on demand (group EDA); and infiltration of bupivacaine into the wound, oral oxycodone hydrochloride, paracetamol, and oral morphine on demand (group OXY) showed no significant difference in postoperative pain or vomiting, in RRP Hohwu et al 2006 Click here for more information
  • The comparison of epidural anaesthesia, combined epidural and general anaesthesia, and general anaesthesia showed no significant difference in mean pain scores in the first 5 POD in RRP Shir et al 1994 Click here for more information
  • The comparison between epidural administration of 15 ml 0.25% bupivacaine and 15 ml 0.5% ropivacaine showed no significant differences in pain scores in RRP Heid et al 2007 Click here for more information
  • Epidural analgesia versus systemic analgesia: Study details
    Click here for more information
  • Peri-operative epidural analgesia versus postoperative epidural analgesia: Study details Click here for more information
  • Epidural analgesia versus local infiltration analgesia: Study details Click here for more information
  • Components of epidural anaesthesia and analgesia: Study details Click here for more information

PROSPECT Recommendations

  • Paravertebral analgesia is not recommended (GoR D) due to limited procedure-specific evidence
  • TAP-blocks are not recommended (GoR D) due to lack of procedure-specific and limited transferable evidence
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • None cited

Transferable Evidence

  • A systematic review including eighteen randomised trials of TAP block in various surgical procedures found analgesic benefit was reported in patients undergoing laparotomy for colorectal surgery, laparoscopic cholecystectomy, and open and laparoscopic appendectomy. However, the authors were unable to definitively identify the surgical procedures, dosing, techniques, and timing that provide optimal analgesia following TAP block Abdallah et al 2012
  • A systematic review of TAP block vs placebo in abdominal surgery included nine studies (n=413) and found a reduction in cumulative morphine use at 24 hours (p<0.0001), a reduction in the incidence of PONV (p=0.003) and a non-significant reduction in VAS pain scores Johns et al 2012
  • In laparoscopic hysterectomy, a 3-arm study compared preoperative ultrasound-guided TAP block plus wound infiltration using two concentrations of ropivacaine (5.0 mg/ml, n=22 and 2.5 mg/ml, n=21) or saline (n=23). NRS pain scores in the PACU were lower for ropivacaine versus saline (p<0.001). 24-hour cumulative opioid consumption was lower with 5.0mg/ml ropivacaine group versus saline (p=0.003) De Oliveira, Milad et al 2011
  • In laparoscopic hysterectomy, a study compared TAP block with 20 ml of 5.0mg/ml ropivacaine (n= 28) performed at the end of the surgical procedure with no block (n=29). NRS pain scores and opioid requirements were similar between groups Kane et al 2012

Radical Prostatectomy-Specific Evidence

PROSPECT Recommendations

  • Intrathecal opioid analgesia is not recommended (GoR B) despite procedure-specific evidence (LoE 1) of analgesic benefit, due to adverse risk:benefit profile (intrathecal anaesthesia is also not recommended). This statement is supported by transferable evidence (LoE 1) from patients undergoing major surgery
  • Voting for: 7; voting against: 1; abstentions: 0

Clinical Practice

  • Spinal analgesia (LA + opioid) has a limited duration of action
  • Spinal morphine may produce some postoperative pain relief but also produces risk of PONV and prolongation of postoperative ileus

Transferable Evidence

  • A meta-analysis of randomized trials included 27 studies comparing intrathecal morphine (dose range 100–4000 µg; without local anaesthetic) with control (placebo/sham injection/no injection) for patients undergoing major surgery with general anaesthesia (n=645). Intrathecal morphine decreased pain scores and opioid requirement up to 24 hours postoperatively Meylan et al 2009
  • A meta-analysis found that intrathecal morphine was associated with increased risk of respiratory depression and pruritis compared with control for patients undergoing major surgery with general anaesthesia (n=645) Meylan et al 2009

Radical Prostatectomy-Specific Evidence

  • Intra-operative intrathecal administration of 4 µg/kg morphine compared with intravenous postoperative morphine by PCA alone (1 mg bolus, 7 min lockout) was superior in reducing pain at 0-18 hours, in RRP. There were no significant differences in PONV Andrieu et al 2009 Click here for more information
  • Patients receiving spinal anaesthesia with sedation had lower pain scores, shorter surgery and less blood loss than patients receiving general anaesthesia Salonia et al 2004 Click here for more information
  • Intra-operative intrathecal administration of bupivacaine (15 mg isobaric, 0.75%), clonidine (75 µg) and morphine (0.2 mg) compared with intravenous bolus of 4 µg/kg fentanyl followed by continuous infusion was superior in significantly reducing pain scores only on the day of surgery, in RRP. Pruritus was significantly greater in the intrathecal group (p<0.001) Brown et al 2004 Click here for more information
  • Study details Click here for more information

PROSPECT Recommendations

  • For open prostatectomy local anaesthetic wound infiltration administered at the end of surgery is recommended (GoR B) because transferable evidence from hernia repair shows analgesic efficacy (LoE1) and because it is a convenient technique with a favourable safety profile, despite limited procedure-specific evidence.
  • For video-assisted prostatectomy local anaesthetic port-site infiltration administered at the end of surgery is recommended (GoR B) because transferable evidence from laparoscopic cholecystectomy shows analgesic efficacy (LoE 1) despite lack of procedure-specific evidence
  • Long-acting local anaesthetics are recommended in preference to short-acting local anaesthetics (GoR D)
  • Continuous local anaesthetic wound infusion is not recommended (GoR B) based on procedure-specific evidence (LoE 2) showing lack of analgesic efficacy
  • Magnesium sulfate wound infiltration is not recommended (GoR D) due to limited procedure-specific evidence
  • Voting for: 8; voting against: 0; abstentions: 0

Clinical Practice

  • Wound infiltration should be used whenever appropriate and possible

Transferable Evidence

  • In herniorraphy, group analysis of all pre-operative local anaesthetic injection techniques (inguinal nerve block/field block/infiltration) showed that they were superior to no treatment or placebo for reducing postoperative pain scores and supplementary analgesic requirements (PROSPECT systematic review) Bugedo et al 1990 Click here for more information
  • In herniorraphy, group analysis of all intra-operative (± pre-operative) local anaesthetic injection techniques (inguinal nerve block/field block/infiltration) showed that they were more effective than placebo for reducing pain scores during the early postoperative period and supplementary analgesic requirements (PROSPECT systematic review) Dierking et al 1994 Click here for more information
  • In herniorraphy, pre-operative local anaesthetic injection was similar to the same regimen given at-closure for pain scores and analgesic use (PROSPECT systematic review) Dierking et al 1992 Click here for more information
  • In laparoscopic cholecystectomy, nine out of 11 studies showed a significant benefit of LA wound infiltration over placebo or no treatment for reducing VAS pain scores (PROSPECT systematic review) Click here for more information
  • A systematic review including 31 studies in laparoscopic cholecystectomy found that local injection of local anaesthetics provided benefits for pain relief but not analgesic consumption for up to 24 h postoperatively. Some studies reported patients with toxic plasma levels of local anaesthetic, without symptoms, and the authors concluded that the dose should be monitored carefully to avoid toxicity (Gupta 2005) Gupta A.
  • In abdominal hysterectomy, there is mixed evidence for a benefit of intra-operative wound infiltration for reducing postoperative pain scores, and the benefits are of marginal clinical significance (PROSPECT systematic review) Cobby et al 1997 Click here for more information
  • A qualitative and quantitative systematic review of intraperitoneal, port-site infiltration and mesosalpinx block showed that port-site infiltration did not reduce postoperative pain after laparoscopy, while intraperitoneal infiltration was associated with a statistically significant but clinically questionable effect on postoperative pain, and mesosalpinx local anaesthetic block reduced postoperative pain to some extent after laparoscopy Møiniche et al 2000

Radical Prostatectomy-Specific Evidence

  • Wound infiltration with 20 ml of 0.5% bupivacaine during surgical closure and 3 ml 75 mg diclofenac (i.m.) compared to saline was superior in reducing pain scores (p<0.001) and cumulative PCA tramadol consumption at 24 h (p<0.001), in RRP Bilgin et al 2011 Click here for more information
  • Infiltration of the incision site with 25% magnesium sulfate 80 mg/kg (Group M), or with the same volume of saline (Group P), under remifentanil-based anaesthesia, or with the same volume of saline under desflurane based anaesthesia (Group D) resulted in significantly higher pain scores in Group P than in Group M for 24 h and Group D for 12 h after surgery, in RALP Lee et al 2011 Click here for more information
  • Co-administration of magnesium sulfate with ropivacaine for postoperative infiltration analgesia produced a significant reduction in tramadol requirements (p<0.001) but showed no significant decrease in pain scores (p=0.40) compared with magnesium sulfate IV 30 min after induction of anaesthesia followed by postoperative infiltration with ropivacaine, in RRP Tauzin-Fin et al 2009 Click here for more information
  • The administration of either 0.5% bupivacaine or normal saline into the wound at a rate of 2 ml/h until discharge on postoperative day 3 resulted in no significant differences in pain scores and PONV, in RRP Wu et al 2005 Click here for more information
  • The comparison between epidural anaesthesia with ropivacaine, paracetamol, injected morphine or oral dextropropoxyphene on demand (group EDA); and infiltration of bupivacaine into the wound, oral oxycodone hydrochloride, paracetamol, and oral morphine on demand (group OXY) showed no significant difference in postoperative pain or vomiting, in RRP Hohwu et al 2006 Click here for more information
  • Wound infiltration or infusion vs placebo: Study details Click here for more information
  • Wound infiltration or infusion vs other: Study details Click here for more information
  • Components of wound infiltration or infusion: Study details Click here for more information