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Meta-Analysis
. 2014 Mar 28;2014(3):CD008261.
doi: 10.1002/14651858.CD008261.pub2.

Pharmacological interventions for prevention or treatment of postoperative pain in people undergoing laparoscopic cholecystectomy

Kurinchi Selvan Gurusamy  1 , Jessica Vaughan, Clare D Toon, Brian R Davidson
Affiliations
Meta-Analysis

Pharmacological interventions for prevention or treatment of postoperative pain in people undergoing laparoscopic cholecystectomy

Kurinchi Selvan Gurusamy et al. Cochrane Database Syst Rev. .

Abstract

Background: While laparoscopic cholecystectomy is generally considered less painful than open surgery, pain is one of the important reasons for delayed discharge after day-surgery and overnight stay following laparoscopic cholecystectomy. The safety and effectiveness of different pharmacological interventions such as non-steroidal anti-inflammatory drugs, opioids, and anticonvulsant analgesics in people undergoing laparoscopic cholecystectomy is unknown.

Objectives: To assess the benefits and harms of different analgesics in people undergoing laparoscopic cholecystectomy.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Science Citation Index Expanded, and the World Health Organization International Clinical Trials Registry Platform portal (WHO ICTRP) to March 2013 to identify randomised clinical trials of relevance to this review.

Selection criteria: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different pharmacological interventions with no intervention or inactive controls for outcomes related to benefit in this review. We considered comparative non-randomised studies with regards to treatment-related harms. We also considered trials that compared one class of drug with another class of drug for this review.

Data collection and analysis: Two review authors collected the data independently. We analysed the data with both fixed-effect and random-effects models using Review Manager 5 analysis. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).

Main results: We included 25 trials with 2505 participants randomised to the different pharmacological agents and inactive controls. All the trials were at unclear risk of bias. Most trials included only low anaesthetic risk people undergoing elective laparoscopic cholecystectomy. Participants were allowed to take additional analgesics as required in 24 of the trials. The pharmacological interventions in all the included trials were aimed at preventing pain after laparoscopic cholecystectomy. There were considerable differences in the pharmacological agents used and the methods of administration. The estimated effects of the intervention on the proportion of participants who were discharged as day-surgery, the length of hospital stay, or the time taken to return to work were imprecise in all the comparisons in which these outcomes were reported (very low quality evidence). There was no mortality in any of the groups in the two trials that reported mortality (183 participants, very low quality evidence). Differences in serious morbidity outcomes between the groups were imprecise across all the comparisons (very low quality evidence). None of the trials reported patient quality of life or time taken to return to normal activity. The pain at 4 to 8 hours was generally reduced by about 1 to 2 cm on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence). The pain at 9 to 24 hours was generally reduced by about 0.5 cm (a modest reduction) on the visual analogue scale of 1 to 10 cm in the comparisons involving the different pharmacological agents and inactive controls (low or very low quality evidence).

Authors' conclusions: There is evidence of very low quality that different pharmacological agents including non-steroidal anti-inflammatory drugs, opioid analgesics, and anticonvulsant analgesics reduce pain scores in people at low anaesthetic risk undergoing elective laparoscopic cholecystectomy. However, the decision to use these drugs has to weigh the clinically small reduction in pain against uncertain evidence of serious adverse events associated with many of these agents. Further randomised clinical trials of low risk of systematic and random errors are necessary. Such trials should include important clinical outcomes such as quality of life and time to return to work in their assessment.

PubMed Disclaimer

Conflict of interest statement

None known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
4
4
Trial sequential analysis of morbidity (non‐steroidal anti‐inflammatory drug (NSAID) versus control) 
 The diversity‐adjusted required information size (DARIS) was calculated to 11,338 participants, based on the proportion of participants in the control group with the outcome of 5.90%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 0%. To account for zero‐event groups, a continuity correction of 0.01 was used in the calculation of the cumulative Z curve (blue line). After accruing 543 participants in five trials, only 4.79% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. As shown, the conventional boundaries have also not been crossed by the cumulative Z curve.
5
5
Trial sequential analysis of pain (4 to 8 hours) (non‐steroidal anti‐inflammatory drug (NSAID) versus control) 
 The diversity‐adjusted required information size (DARIS) was 2050 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 4.51, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 93.07%. The conventional statistical boundaries (dotted red line) are crossed by the cumulative Z curve (blue line) after the third trial. The trial sequential monitoring boundaries (red line) are crossed by cumulative Z curve after the fifth trial. Although the DARIS has not been reached, the findings are consistent with NSAID decreasing pain between 4 and 8 hours compared with inactive control with low risk of random errors.
6
6
Trial sequential analysis of pain (9 to 24 hours) (non‐steroidal anti‐inflammatory drug (NSAID) versus control) 
 The diversity‐adjusted required information size (DARIS) was 1525 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 2.62, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 94.56%. The conventional statistical boundaries (dotted red line) are crossed by the cumulative Z curve (blue line) after the third trial. The trial sequential monitoring boundaries (red line) are crossed by cumulative Z curve after the fifth trial. Although the DARIS has not been reached, the findings are consistent with NSAID decreasing pain between 9 and 24 hours compared with inactive control with low risk of random errors.
7
7
Trial sequential analysis of pain (4 to 8 hours) (opioid versus control) 
 The diversity‐adjusted required information size (DARIS) was 445 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 14.16, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. The conventional statistical boundaries (dotted red line) and the trial sequential monitoring boundaries (red line) are crossed by the cumulative Z curve (blue line) after the first trial. Although the DARIS is not reached, the findings are consistent with opioid decreasing pain between 4 and 8 hours compared with inactive control with low risk of random errors.
8
8
Trial sequential analysis of pain (9 to 24 hours) (opioid versus control) 
 The diversity‐adjusted required information size (DARIS) was 25 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 0.78, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. As this was crossed by the first trial, the trial sequential boundaries were not drawn. A post‐hoc analysis with the MIRD revised to 0.25 cm was performed. The conventional statistical boundaries (dotted red line) and trial sequential monitoring boundaries (red line) are crossed by cumulative Z curve (blue line) after the first trial. Although the DARIS has not been reached, the findings are consistent with opioid decreasing pain between 9 and 24 hours compared with inactive control with low risk of random errors.
9
9
Trial sequential analysis of pain (4 to 8 hours) (anticonvulsant analgesics versus control) 
 The diversity‐adjusted required information size (DARIS) was 4571 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 9.56, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 93.42%. The conventional statistical boundaries (dotted red line) are crossed by the cumulative Z curve (blue line) after the third trial. After accruing 402 participants in three trials, only 8.79% of DARIS has been reached. Accordingly, the futility area is not shown. The conventional monitoring boundaries (dotted red line) are crossed by the cumulative Z curve (blue line) after the first trial. The trial sequential monitoring boundaries (red line) are not crossed by cumulative Z curve. The findings are consistent with high risk of random errors even though there is a statistically significant reduction in pain in the anticonvulsant analgesic group compared with the control group.
10
10
Trial sequential analysis of pain (9 to 24 hours) (anticonvulsant analgesics versus control) 
 The diversity‐adjusted required information size (DARIS) was 28 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 0.88, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. As this was crossed by the first trial, the trial sequential boundaries were not drawn. A post‐hoc analysis with the MIRD revised to 0.25 cm was performed. The conventional statistical boundaries (dotted red line) and the trial sequential monitoring boundaries (red line) are crossed by the cumulative Z curve (blue line) after the first trial. Although the DARIS has not been reached, the findings are consistent with anticonvulsant analgesics decreasing pain between 9 and 24 hours compared with inactive control with low risk of random errors.
1.1
1.1. Analysis
Comparison 1 NSAID versus control, Outcome 1 Morbidity.
1.2
1.2. Analysis
Comparison 1 NSAID versus control, Outcome 2 Proportion discharged as day‐surgery.
1.3
1.3. Analysis
Comparison 1 NSAID versus control, Outcome 3 Length of hospital stay.
1.4
1.4. Analysis
Comparison 1 NSAID versus control, Outcome 4 Pain (4 to 8 hours).
1.5
1.5. Analysis
Comparison 1 NSAID versus control, Outcome 5 Pain (9 to 24 hours).
1.6
1.6. Analysis
Comparison 1 NSAID versus control, Outcome 6 Morbidity (sensitivity analysis).
1.7
1.7. Analysis
Comparison 1 NSAID versus control, Outcome 7 Proportion discharged as day‐surgery (sensitivity analysis).
1.8
1.8. Analysis
Comparison 1 NSAID versus control, Outcome 8 Pain (4 to 8 hours) sensitivity analysis.
1.9
1.9. Analysis
Comparison 1 NSAID versus control, Outcome 9 Pain (9 to 24 hours) sensitivity analysis.
1.10
1.10. Analysis
Comparison 1 NSAID versus control, Outcome 10 Pain (4 to 8 hours) stratified by drug.
1.11
1.11. Analysis
Comparison 1 NSAID versus control, Outcome 11 Pain (4 to 8 hours) stratified by time.
1.12
1.12. Analysis
Comparison 1 NSAID versus control, Outcome 12 Pain (9 to 24 hours) stratified by drug.
1.13
1.13. Analysis
Comparison 1 NSAID versus control, Outcome 13 Pain (9 to 24 hours) stratified by time.
2.1
2.1. Analysis
Comparison 2 Opioid versus control, Outcome 1 Pain (4 to 8 hours).
2.2
2.2. Analysis
Comparison 2 Opioid versus control, Outcome 2 Pain (9 to 24 hours).
2.3
2.3. Analysis
Comparison 2 Opioid versus control, Outcome 3 Pain (4 to 8 hours) (sensitivity analysis).
2.4
2.4. Analysis
Comparison 2 Opioid versus control, Outcome 4 Pain (9 to 24 hours) (sensitivity analysis).
3.1
3.1. Analysis
Comparison 3 Anticonvulsant analgesic versus control, Outcome 1 Morbidity.
3.2
3.2. Analysis
Comparison 3 Anticonvulsant analgesic versus control, Outcome 2 Pain (4 to 8 hours).
3.3
3.3. Analysis
Comparison 3 Anticonvulsant analgesic versus control, Outcome 3 Pain (9 to 24 hours).
3.4
3.4. Analysis
Comparison 3 Anticonvulsant analgesic versus control, Outcome 4 Morbidity (sensitivity analysis).
3.5
3.5. Analysis
Comparison 3 Anticonvulsant analgesic versus control, Outcome 5 Pain (4 to 8 hours) sensitivity analysis.
3.6
3.6. Analysis
Comparison 3 Anticonvulsant analgesic versus control, Outcome 6 Pain (9 to 24 hours) sensitivity analysis.
4.1
4.1. Analysis
Comparison 4 Anticonvulsant analgesic versus NSAID, Outcome 1 Morbidity.
4.2
4.2. Analysis
Comparison 4 Anticonvulsant analgesic versus NSAID, Outcome 2 Pain (4 to 8 hours).
4.3
4.3. Analysis
Comparison 4 Anticonvulsant analgesic versus NSAID, Outcome 3 Pain (9 to 24 hours).
4.4
4.4. Analysis
Comparison 4 Anticonvulsant analgesic versus NSAID, Outcome 4 Morbidity (sensitivity analysis).
5.1
5.1. Analysis
Comparison 5 Anticonvulsant analgesic versus opioid, Outcome 1 Pain (4 to 8 hours).
5.2
5.2. Analysis
Comparison 5 Anticonvulsant analgesic versus opioid, Outcome 2 Pain (9 to 24 hours).
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD008261

References

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References to studies excluded from this review

Aftab 2008 {published data only}
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Stempin 2007 {published data only}
    1. Stempin S, Gajdosz R. Intraperitoneal morphine for prevention of postoperative shoulder pain after laparoscopic cholecystectomy. Anestezjologia Intensywna Terapia 2007;39(1):18‐20.
Tiippana 2008 {published data only}
    1. Tiippana E, Bachmann M, Kalso E, Pere P. Effect of paracetamol and coxib with or without dexamethasone after laparoscopic cholecystectomy. Acta Anaesthesiologica Scandinavica 2008;52(5):673‐80. - PubMed
Wininger 2010 {published data only}
    1. Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, et al. A randomized, double‐blind, placebo‐controlled, multicenter, repeat‐dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clinical Therapeutics 2010;32(14):2348‐69. - PubMed
Wu 1999 {published data only}
    1. Wu CT, Yu JC, Yeh CC, Liu ST, Li CY, Ho ST, et al. Preincisional dextromethorphan treatment decreases postoperative pain and opioid requirement after laparoscopic cholecystectomy. Anesthesia and Analgesia 1999;88(6):1331‐4. - PubMed
Wu 2005 {published data only}
    1. Wu CT, Borel CO, Lee MS, Yu JC, Liou HS, Yi HD, et al. The interaction effect of perioperative cotreatment with dextromethorphan and intravenous lidocaine on pain relief and recovery of bowel function after laparoscopic cholecystectomy. Anesthesia and Analgesia 2005;100(2):448‐53. - PubMed
Yamazaki 2003 {published data only}
    1. Yamazaki E, Murao K, Asai T, Matsumoto S, Shingu K. Comparison of analgesic effects of intravenous flurbprofen and suppository indomethacin after laparoscopic cholecystectomy. Masui. The Japanese Journal of Anesthesiology 2003;52(11):1186‐90. - PubMed
Zambouri 2002 {published data only}
    1. Zambouri A, Petropoulou P, Petra K, Ralli M, Douvantzi A, Papachristou D. Do early postoperative pain, nausea and vomiting really differ when remifentanil or fentanyl are used in laparoscopic cholecystectomy?. 10th World Society of Pain Clinicians of the International Pain Clinic; 2002 May 04‐08, Sardinia, Italy. World Society of Pain Clinicians, 2002:257‐63.
Zghidi 2011 {published data only}
    1. Zghidi SM, Jaoua H, Ghariani S, Saada S, Laabidi S, Khemiri K, et al. Effectiveness of dexamethasone in postoperative analgesia after laparoscopic cholecystectomy. Regional Anesthesia and Pain Medicine 2011;2:E278‐9.

References to studies awaiting assessment

Gan 2003 {published data only}
    1. Gan TJ, Joshi G, Viscusi E, Chen C, Cheung R. Postdischarge recovery experience after single presurgery does of IV parecoxib sodium, a novel COX‐2 inhibitor, followed by oral valdecoxib for pain after laparoscopic cholecystectomy. International Journal of Obstetrics & Gynecology 2003;83(3):23.

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