Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy

Duncan Rutherford, Eleanor M Massie, Calum Worsley, Michael Sj Wilson, Duncan Rutherford, Eleanor M Massie, Calum Worsley, Michael Sj Wilson

Abstract

Background: Pain is one of the important reasons for delayed discharge after laparoscopic cholecystectomy. Use of intraperitoneal local anaesthetic for laparoscopic cholecystectomy may be a way of reducing pain. A previous version of this Cochrane Review found very low-certainty evidence on the benefits and harms of the intervention.

Objectives: To assess the benefits and harms of intraperitoneal instillation of local anaesthetic agents in people undergoing laparoscopic cholecystectomy.

Search methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, and three other databases to 19 January 2021 together with reference checking of studies retrieved. We also searched five online clinical trials registries to identify unpublished or ongoing trials to 10 September 2021. We contacted study authors to identify additional studies.

Selection criteria: We only considered randomised clinical trials (irrespective of language, blinding, publication status, or relevance of outcome measure) comparing local anaesthetic intraperitoneal instillation versus placebo, no intervention, or inactive control during laparoscopic cholecystectomy, for the review. We excluded non-randomised studies, and studies where the method of allocating participants to a treatment was not strictly random (e.g. date of birth, hospital record number, or alternation).

Data collection and analysis: Two review authors collected the data independently. Primary outcomes included all-cause mortality, serious adverse events, and quality of life. Secondary outcomes included length of stay, pain, return to activity and work, and non-serious adverse events. The analysis included both fixed-effect and random-effects models using RevManWeb. We performed subgroup, sensitivity, and meta-regression analyses. For each outcome, we calculated the risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CIs). We assessed risk of bias using predefined domains, graded the certainty of the evidence using GRADE, and presented outcome results in a summary of findings table.

Main results: Eighty-five completed trials were included, of which 76 trials contributed data to one or more of the outcomes. This included a total of 4957 participants randomised to intraperitoneal local anaesthetic instillation (2803 participants) and control (2154 participants). Most trials only included participants undergoing elective laparoscopic cholecystectomy and those who were at low anaesthetic risk (ASA I and II). The most commonly used local anaesthetic agent was bupivacaine. Methods of instilling the local anaesthetic varied considerably between trials; this included location and timing of application. The control groups received 0.9% normal saline (69 trials), no intervention (six trials), or sterile water (two trials). One trial did not specify the control agent used. None of the trials provided information on follow-up beyond point of discharge from hospital. Only two trials were at low risk of bias. Seven trials received external funding, of these three were assessed to be at risk of conflicts of interest, a further 17 trials declared no funding. We are very uncertain about the effect intraperitoneal local anaesthetic versus control on mortality; zero mortalities in either group (8 trials; 446 participants; very low-certainty evidence); serious adverse events (RR 1.07; 95% CI 0.49 to 2.34); 13 trials; 988 participants; discharge on same day of surgery (RR 1.43; 95% CI 0.64 to 3.20; 3 trials; 242 participants; very low-certainty evidence). We found that intraperitoneal local anaesthetic probably results in a small reduction in length of hospital stay (MD -0.10 days; 95% CI -0.18 to -0.01; 12 trials; 936 participants; moderate-certainty evidence). No trials reported data on health-related quality of life, return to normal activity or return to work. Pain scores, as measured by visual analogue scale (VAS), were lower in the intraperitoneal local anaesthetic instillation group compared to the control group at both four to eight hours (MD -0.99 cm VAS; 95% CI -1.19 to -0.79; 57 trials; 4046 participants; low-certainty of evidence) and nine to 24 hours (MD -0.68 cm VAS; 95% CI -0.88 to -0.49; 52 trials; 3588 participants; low-certainty of evidence). In addition, we found two trials that were still ongoing, and one trial that was completed but with no published results. All three trials are registered on the WHO trial register.

Authors' conclusions: We are very uncertain about the effect estimate of intraperitoneal local anaesthetic for laparoscopic cholecystectomy on all-cause mortality, serious adverse events, and proportion of patients discharged on the same day of surgery because the certainty of evidence was very low. Due to inadequate reporting, we cannot exclude an increase in adverse events. We found that intraperitoneal local anaesthetic probably results in a small reduction in length of stay in hospital after surgery. We found that intraperitoneal local anaesthetic may reduce pain at up to 24 hours for low-risk patients undergoing laparoscopic cholecystectomy. Future randomised clinical trials should be at low risk of systematic and random errors, should fully report mortality and side effects, and should focus on clinical outcomes such as quality of life.

Conflict of interest statement

DR: nothing to declare.

EM: nothing to declare.

CW: nothing to declare.

MW: nothing to declare.

Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Figures

1
1
Date of search of electronic databases: 19 January 2021. Last date of search of online clinical trials registries and other sources: 10 September 2021.
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 serious adverse events
The diversity‐adjusted required information size (DARIS) was calculated to 50,949 participants, based on the proportion of participants in the control group with the outcome of 2.15%, a relative risk reduction of 20%, an alpha of 2.5%, a beta of 10%, and a diversity of 0%. After accruing 988 participants in 13 trials, only 1.9% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the required information size and the trial sequential monitoring boundaries. The conventional boundaries (green dotted line) denoting an alpha of 5% have also not been crossed by the cumulative Z‐curve.
5
5
Trial Sequential Analysis of length of hospital stay
The diversity‐adjusted required information size (DARIS) was 775 participants based on a a minimal relevant difference of 0.5 days (see Sensitivity analysis), a variance (VAR) of 3.39, an alpha (a) of 1.25%, a beta (b) of 10%, and a diversity (D2) of 0%. After accruing 938 participants in twelve trials, the cumulative Z‐curve (blue line) has crossed the trial sequential monitoring boundaries (red line) but lies within the futility area and the conventional statistical boundaries (green dotted line). This suggests that it is unlikely that future trials are likely to demonstrate any significant difference in the length of hospital stay between local anaesthetic instillation and no local anaesthetic instillation.
6
6
7
7
Trial Sequential Analysis of pain (4 to 8 hours)
The diversity‐adjusted required information size (DARIS) was 1095 participants based on a minimal relevant difference (MIRD) of 1.18 cm on the visual analogue scale, a variance (VAR) of 3.92, an alpha (a) of 1.25%, a beta (b) of 10%, and a diversity (D2) of 88%. The conventional statistical boundaries (green dotted line) are crossed by the cumulative Z‐curve (blue line) after the second trial. All the trial sequential monitoring boundaries (red line) are crossed by cumulative Z‐curve after the eighth trial. The findings are consistent with local anaesthetic instillation decreasing pain between 4 and 8 hours compared with no local anaesthetic instillation without the risk of random errors.
8
8
Trial Sequential Analysis of pain (9 to 24 hours)
The diversity‐adjusted required information size (DARIS) was 2920 participants based on a minimal relevant difference (MIRD) of 1.01 cm on the visual analogue scale, a variance (VAR) of 4.97, an alpha (a) of 1.25%, a beta (b) of 10%, and a diversity (D2) of 90%. The conventional statistical boundaries (dotted red line) are crossed by the cumulative Z‐curve (blue line) after the first trial. The cumulative Z‐curve (green dotted line) did crossed the trial sequential monitoring boundaries for benefit or harm (red inward sloping lines) after the 16th trial. The findings are consistent with local anaesthetic instillation decreasing pain between 9 and 24 hours compared to no local anaesthetic instillation without the risk of random errors.
1.1. Analysis
1.1. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 1: Mortality
1.2. Analysis
1.2. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 2: Serious adverse events
1.3. Analysis
1.3. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 3: Hospital stay
1.4. Analysis
1.4. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 4: Proportion discharged as day surgery
1.5. Analysis
1.5. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 5: Pain (4 to 8 hours)
1.6. Analysis
1.6. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 6: Pain (9 to 24 hours)
1.7. Analysis
1.7. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 7: Non‐significant adverse events
1.8. Analysis
1.8. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 8: Individual serious adverse events
1.9. Analysis
1.9. Analysis
Comparison 1: Local anaesthetic versus no local anaesthetic, Outcome 9: Individual non serious adverse events
2.1. Analysis
2.1. Analysis
Comparison 2: Sensitivity analysis, Outcome 1: Mortality
2.2. Analysis
2.2. Analysis
Comparison 2: Sensitivity analysis, Outcome 2: Serious adverse events
2.3. Analysis
2.3. Analysis
Comparison 2: Sensitivity analysis, Outcome 3: Hospital stay (studies with imputed values removed)
2.4. Analysis
2.4. Analysis
Comparison 2: Sensitivity analysis, Outcome 4: Proportion discharged as day surgery
2.5. Analysis
2.5. Analysis
Comparison 2: Sensitivity analysis, Outcome 5: Pain (4 to 8 hours) (studies with imputed values removed)
2.6. Analysis
2.6. Analysis
Comparison 2: Sensitivity analysis, Outcome 6: Pain (9 to 24 hours) (studies with imputed values removed)
3.1. Analysis
3.1. Analysis
Comparison 3: Subgroup analysis, Outcome 1: Pain (4 to 8 hours) by local anaesthetic
3.2. Analysis
3.2. Analysis
Comparison 3: Subgroup analysis, Outcome 2: Pain (4 to 8 hours) by form
3.3. Analysis
3.3. Analysis
Comparison 3: Subgroup analysis, Outcome 3: Pain (4 to 8 hours) by time
3.4. Analysis
3.4. Analysis
Comparison 3: Subgroup analysis, Outcome 4: Pain (4 to 8 hours) by location
3.5. Analysis
3.5. Analysis
Comparison 3: Subgroup analysis, Outcome 5: Pain (4 to 8 hours) by wound infiltration
3.6. Analysis
3.6. Analysis
Comparison 3: Subgroup analysis, Outcome 6: Pain (4 to 8 hours) by routine supplemental analgesia
3.7. Analysis
3.7. Analysis
Comparison 3: Subgroup analysis, Outcome 7: Pain (4 to 8 hours) by drain use
3.8. Analysis
3.8. Analysis
Comparison 3: Subgroup analysis, Outcome 8: Pain (4 to 8 hours) by vested interests
3.9. Analysis
3.9. Analysis
Comparison 3: Subgroup analysis, Outcome 9: Pain (4 to 8 hours) by control use
3.10. Analysis
3.10. Analysis
Comparison 3: Subgroup analysis, Outcome 10: Pain (9 to 24 hours) by local anaesthetic
3.11. Analysis
3.11. Analysis
Comparison 3: Subgroup analysis, Outcome 11: Pain (9 to 24 hours) by form
3.12. Analysis
3.12. Analysis
Comparison 3: Subgroup analysis, Outcome 12: Pain (9 to 24 hours) by time
3.13. Analysis
3.13. Analysis
Comparison 3: Subgroup analysis, Outcome 13: Pain (9 to 24 hours) by location
3.14. Analysis
3.14. Analysis
Comparison 3: Subgroup analysis, Outcome 14: Pain (9 to 24 hours) by wound infiltration
3.15. Analysis
3.15. Analysis
Comparison 3: Subgroup analysis, Outcome 15: Pain (9 to 24 hours) by routine supplemental analgesia
3.16. Analysis
3.16. Analysis
Comparison 3: Subgroup analysis, Outcome 16: Pain (9 to 24 hours) by drain
3.17. Analysis
3.17. Analysis
Comparison 3: Subgroup analysis, Outcome 17: Pain (9 to 24 hours) by vested interest
3.18. Analysis
3.18. Analysis
Comparison 3: Subgroup analysis, Outcome 18: Pain (9 to 24 hours) by control used

References

References to studies included in this review Abdel‐Raouf 2004 {published data only}

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Ahmad 1998 {published data only}
    1. Ahmad SM, Hassanally D, Harris G, Simson J. Is local and intraperitoneal instillation of bupivacaine after laparoscopic cholecystectomy effective for pain? British Journal of Surgery 1998;85(Suppl 1):47.
Alagöl 2003 {published data only}
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Alkhamesi 2007 {published data only}
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Alper 2009 {published data only}
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Beder El Baz 2018 {published data only}12209062
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Bhardwaj 2002 {published data only}
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Das 2017 {published data only}
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Fornari 1996 {published data only}
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Fu 2009 {published data only}
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Fuhrer 1996 {published data only}
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Garcia 2007 {published data only}
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Golubovic 2009 {published data only}
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Govil 2017 {published data only}
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Gumusoglu 2020 {published data only}
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Gupta 2016 {published data only}12209066
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Gvozdenovic 2011 {published data only}
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Hasan 2007 {published data only}
    1. Hasan S, Lauwers M, Van H, Van NY, Camu F. Postoperative vain relief after laparoscopic cholecystectomy. A placebo-controlled randomized trial of local infiltration and intra peritoneal administration of ropivacaine 0.25%. Acta Anaesthesiologica Belgica 2007;58(2):150.
Hazinedaroglu 2006 {published data only}
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Honca 2014 {published data only}
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Ingelmo 2013 {published data only}
    1. Ingelmo PM, Bucciero M, Somaini M, Sahillioglu E, Garbagnati A, Charton A, et al. Intraperitoneal nebulization of ropivacaine for pain control after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial. British Journal of Anaesthesia 2013;110(5):800-6. [DOI: 10.1093/bja/aes495]
Jabbour‐Khoury 2005 {published data only}
    1. Jabbour-Khoury SI, Dabbous AS, Gerges FJ, Azar MS, Ayoub CM, Khoury GS. Intraperitoneal and intravenous routes for pain relief in laparoscopic cholecystectomy. Journal of the Society of Laparoendoscopic Surgeons 2005;9(3):316-21.
Jain 2018 {published data only}
    1. Jain S, Nazir N, Singh S, Sharma S. A prospective randomised controlled study for evaluation of high-volume low-concentration intraperitoneal bupivacaine for post-laparoscopic cholecystectomy analgesia. Indian Journal of Anaesthesia 2018;62(2):109-4. [DOI: 10.4103/ija.IJA_87_17]
Jiranantarat 2002 {published data only}
    1. Jiranantarat V, Rushatamukayanunt W, Lert-Akyamanee N, Sirijearanai R, Piromrat I, Suwannanonda P, et al. Analgesic effect of intraperitoneal instillation of bupivacaine for postoperative laparoscopic cholecystectomy. Journal of the Medical Association of Thailand 2002;85(Suppl 3):S897-S903.
Joris 1995 {published data only}
    1. Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesthesia and Analgesia 1995;81(2):379-84.
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Kallel 2011 {published data only}
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Karaaslan 2006 {published data only}
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Karadeniz 2003 {published data only}
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Karaman 2014 {published data only}
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Khurana 2016 {published data only}
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Kilic 1996 {published data only}
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Kim 2010 {published data only}
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Kolsi 2000 {published data only}
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Kucuk 2007 {published data only}
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Labaille 2002 {published data only}
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Lee 2001 {published data only}
    1. Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, et al. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Canadian Journal of Anaesthesia 2001;48(6):545-50.
Lepner 2003 {published data only}
    1. Lepner U, Goroshina J, Samarütel J. Postoperative pain relief after laparoscopic cholecystectomy: a randomised prospective double-blind clinical trial. Scandinavian Journal of Surgery 2003;92(2):121-4.
Liu 2015 {published data only}
    1. Liu D-S, Guan F, Wang B, Zhang T. Combined usage with intraperitoneal and incisional ropivacaine reduces pain severity after laparoscopic cholecystectomy. International Journal of Clinical and Experimental Medicine 2015;8(12):22460-8.
Louizos 2005 {published data only}
    1. Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG, Bramis JP. Postoperative pain relief after laparoscopic cholecystectomy: a placebo-controlled double-blind randomized trial of preincisional infiltration and intraperitoneal instillation of levobupivacaine 0.25%. Surgical Endoscopy 2005;19(11):1503-6.
Maestroni 2002 {published data only}
    1. Maestroni U, Sortini D, Devito C, Pour-Morad-Kohan-Brunaldi F, Anania-Pavanelli L, Pasqualucci A, et al. A new method of preemptive analgesia in laparoscopic cholecystectomy. Surgical Endoscopy 2002;16(9):1336-40.
Manan 2020 {published data only}
    1. Manan A, Khan AA, Ahmad I, Usman M, Jamil T, Sajid MA. Intraperitoneal bupivacaine as post-laparoscopic cholecystectomy analgesia. Journal of the College of Physicians and Surgeons--Pakistan 2020;30(1):9-12.
Maranon 2017 {published data only}
    1. Maranon GJ, Siozon MV, Domino JJ, Amado RS, Genuino BB, Madrid RM. Post-operative pain relief by infiltration of periportal anesthesia versus intraperitoneal and periportal anesthesia in laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques 2017;31(2):74.
Melidi 2016 {published data only}
    1. Melidi E, Papadima A, Pandazi A, Zografos G. Efficacy of repeated intraperitoneal administration of levobupivacaine in pain and opioid consumption after elective laparoscopic cholecystectomy: a prospective randomized placebo-controlled trial. Surgical Laparoscopy, Endoscopy & Percutaneous Techniques 2016;26(4):295-300. [DOI: 10.1097/SLE.0000000000000297]
Mraovic 1997 {published data only}
    1. Mraovic B, Jurisic T, Kogler-Majeric V, Sustic A. Intraperitoneal bupivacaine for analgesia after laparoscopic cholecystectomy. Acta Anaesthesiologica Scandinavica 1997;41(2):193-6.
Ng 2004 {published data only}
    1. Ng A, Swami A, Smith G, Robertson G, Lloyd DM. Is intraperitoneal levobupivacaine with epinephrine useful for analgesia following laparoscopic cholecystectomy? A randomized controlled trial. European Journal of Anaesthesiology 2004;21(8):653-7.
Nicolau 2008 {published data only}
    1. Nicolau AE, Merlan V, Grecu I, Nicolau M, Micu B. Multimodal analgesia in elective laparoscopic cholecystectomy. A double-blind randomized control trial. Chirurgia 2008;103(5):547-51. [1221-9118]
Niknam 2014 {published data only}
    1. Niknam F, Saxena A, Niles N, Budak Ulvi U, Mekisic A. Does irrigation of the subdiaphragmatic region with ropivacaine reduce the incidence of right shoulder tip pain after laparoscopic cholecystectomy? A prospective randomized, double-blind, controlled study. American Surgeon 2014;80(1):17-8. [DOI: 10.1177/000313481408000112]
Nupur 2014 {published data only}
    1. Nupur C, Shubha S, Vinayak SR. Evaluation of intraperitoneal bupivacaine for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: a prospective randomized trial. Anaesthesia, Pain and Intensive Care 2014;18(4):361-6.
Pappas‐Gogos 2008 {published data only}
    1. Pappas-Gogos G, Tsimogiannis KE, Zikos N, Nikas K, Manataki A, Tsimoyiannis EC. Preincisional and intraperitoneal ropivacaine plus normal saline infusion for postoperative pain relief after laparoscopic cholecystectomy: a randomized double-blind controlled trial. Surgical Endoscopy 2008;22(9):2036-45.
Pasqualucci 1994 {published data only}
    1. Pasqualucci A, Contardo R, Da Broi U, Colo F, Terrosu G, Donini A, et al. The effects of intraperitoneal local anesthetic on analgesic requirements and endocrine response after laparoscopic cholecystectomy: a randomized double-blind controlled study. Journal of Laparoendoscopic Surgery 1994;4(6):405-12.
Pasqualucci 1996 {published data only}
    1. Pasqualucci A, De Angelis V, Contardo R, Colo F, Terrosu G, Donini A, et al. Preemptive analgesia: intraperitoneal local anesthetic in laparoscopic cholecystectomy: a randomized, double-blind, placebo-controlled study. Anesthesiology 1996;85(1):11-20.
Paulson 2003 {published data only}
    1. Paulson J, Mellinger J, Baguley W. The use of intraperitoneal bupivacaine to decrease the length of stay in elective laparoscopic cholecystectomy patients. 45th Annual Meeting of the Midwest-Surgical-Association 2002:275-8.
    1. Paulson J, Mellinger J, Baguley W. The use of intraperitoneal bupivacaine to decrease the length of stay in elective laparoscopic cholecystectomy patients. American Surgeon 2003;69(4):275-9.
Putta 2019 {published data only}
    1. Putta P, Pasupuleti H, Samantaray A, Natham H, Rao M. A comparative evaluation of pre-emptive versus post-surgery intraperitoneal local anaesthetic instillation for postoperative pain relief after laparoscopic cholecystectomy: a prospective, randomised, double blind and placebo controlled study. Indian Journal of Anaesthesia 2019;63(3):205-11. [DOI: 10.4103/ija.IJA-767-18]
Rademaker 1994 {published data only}
    1. Rademaker BM, Kalkman CJ, Odoom JA, Dewit L, Ringers J. Intraperitoneal local-anesthetics after laparoscopic cholecystectomy - effects on postoperative pain, metabolic responses and lung-function. British Journal of Anaesthesia 1994;72(3):263-6.
Raetzell 1995a {published data only}
    1. Raetzell M, Maier C, Schroder D, Wulf H. Intraperitoneal application of bupivacaine during laparoscopic cholecystectomy - risk or benefit? Anesthesia and Analgesia 1995;81(5):967-72.
Raetzell 1995b {published data only}
    1. Raetzell M, Maier C, Schroder D, Wulf H. Intraperitoneal application of bupivacaine during laparoscopic cholecystectomy - risk or benefit? Anesthesia and Analgesia 1995;81(5):967-72.
Razek 2003 {published data only}
    1. Razek EA. Intraperitoneal levobupivacaine for analgesia after laparoscopic cholecystectomy. Egyptian Journal of Anaesthesia 2003;19(3):249-54.
Razman 2010 {published data only}
    1. Razman J, Ramasamy R, Yan YW, Muthupalaniappan K. Intraperitoneal 0.5% bupivacaine instillation in trendelenburg position for postoperative pain relief in laparoscopic cholecystectomy. HPB : the official journal of the International Hepato Pancreato Biliary Association 2010;12(Suppl S1):106-7.
Roberts 2011 {published data only}
    1. Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques 2011;25(11):3698-705.
Roberts 2013 {published data only}
    1. Roberts KJ, Gilmour J, Pande R, Hodson J, Lam T, Khan S. Double-blind randomized sham controlled trial of intraperitoneal bupivacaine during emergency laparoscopic cholecystectomy. Hepatobiliary & Pancreatic Diseases International 2013;12(3):310-6. [DOI: 10.1016/S1499-3872%2813%2960049-1]
Rudra 2002 {published data only}
    1. Rudra A, Biswas BN, Mukhopadhya S, Mukhopadhya M, Bagchi D, Bar B. Intraperitoneal bupivacaine for pain relief after laparoscopic cholecystectomy. Journal of Anaesthesiology, Clinical Pharmacology 2002;18(4):409-11.
Scheinin 1995 {published data only}
    1. Scheinin B, Kellokumpu I, Lindgren L, Haglund C, Rosenberg PH. Effect of intraperitoneal bupivacaine on pain after laparoscopic cholecystectomy. Acta Anaesthesiologica Scandinavica 1995;39(2):195-8.
Singh 2017 {published data only}
    1. Singh S, Giri MK, Singh M, Giri NK. A clinical comparative study of intraperitoneal instillation of ropivacaine alone or ropivacaine with nalbuphine for postoperative analgesia in laparoscopic cholecystectomy. Anaesthesia, Pain and Intensive Care 2017;21(3):335-9.
Szem 1996 {published data only}
    1. Szem JW, Hydo L, Barie PS. A double-blinded evaluation of intraperitoneal bupivacaine vs saline for the reduction of postoperative pain and nausea after laparoscopic cholecystectomy. Surgical Endoscopy 1996;10(1):44-8.
Todorov 2009 {published data only}
    1. Todorov G, Tzaneva P, Lukanova T, Velev G, Kojtchev A. The effect of intraperitoneal levobupivacain (Chirocaine) application on postoperative pain in laparoscopic cholecystectomy - a prospective study. Khirurgiia 2009;4-5:32-5.
Toleska 2018 {published data only}
    1. Toleska M, Kartalov A, Kuzmanovska B, Panovski M, Shosholcheva M, Dimitrovski A, et al. Efficacy of intraperitoneal bupivacaine on pain relief after laparoscopic cholecystectomy. Prilozi Makedonska Akademija NA Naukite I Umetnostite Oddelenie Za Medicinski Nauki 2018;39(1):123-9. [DOI: 10.2478/prilozi-2018-0032]
Topno 2018 {published data only}
    1. Topno N, Baruah AJ, Ghosh S, Saikia J, Tongper D, Komut O. Intraperitoneal analgesia instillation for postoperative pain relief after laparoscopic cholecystectomy. Journal of Clinical and Diagnostic Research 2018;12(7):PC10-3. [DOI: 10.7860/JCDR/2018/30979.11759]
Tsimoyiannis 1998a {published data only}
    1. Tsimoyiannis EC, Glantzounis G, Lekkas ET, Siakas P, Jabarin M, Tzourou H. Intraperitoneal normal saline and bupivacaine infusion for reduction of postoperative pain after laparoscopic cholecystectomy. Surgical Laparoscopy & Endoscopy 1998;8(6):416-20.
Tunca 2001 {published data only}
    1. Tunca T, Basoglu M, Kürsat H, Cesur M. The evaluation of the effects of intraperitoneal morphine+bupivacaine versus bupivacaine for postoperative analgesia. Turk Anesteziyoloji ve Reanimasyon 2001;29(6):281-4.
Verma 2006 {published data only}
    1. Verma GR, Lyngdoh TS, Kaman L, Bala I. Placement of 0.5% bupivacaine-soaked Surgicel in the gallbladder bed is effective for pain after laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques 2006;20(10):1560-4.
Wasim 2015 {published data only}
    1. Wasim M, Shafqatullah S. Role of intraperitoneal bupivacaine in laparoscopic cholecystectomy. HPB : the official journal of the International Hepato Pancreato Biliary Association 2015;17:32-3.
Weber 1997 {published data only}
    1. Weber A, Muñoz J, Garteiz D, Cueto J. Use of subdiaphragmatic bupivacaine instillation to control postoperative pain after laparoscopic surgery. Surgical Laparoscopy & Endoscopy 1997;7(1):6-8.
Yang 2014 {published data only}
    1. Yang SY, Kang H, Choi GJ, Shin HY, Baek CW, Jung YH, et al. Efficacy of intraperitoneal and intravenous lidocaine on pain relief after laparoscopic cholecystectomy. Journal of International Medical Research 2014;42(1):307-19.
Yari 2014 {published data only}
    1. Yari M, Rooshani B, Golfam P, Nazari N. Intraperitoneal bupivacaine effect on postoperative nausea and vomiting following laparoscopic cholecystectomy. Regional Anesthesia and Pain Medicine 2014;4(3):e16710. [DOI: 10.5812/aapm.16710]
Zimmer 2010 {published data only}
    1. Zimmer PW, McCann MJ, O'Brien MM. Bupivacaine use in the insuflow device during laparoscopic cholecystectomy: results of a prospective randomized double-blind controlled trial. Surgical Endoscopy 2010;24(7):1524-7.
Zmora 2000 {published data only}
    1. Zmora O, Stolik-Dollberg O, Bar-Zakai B, Rosin D, Kuriansky J, Shabtai M, et al. Intraperitoneal bupivacaine does not attenuate pain following laparoscopic cholecystectomy. JSLS : Journal of the Society of Laparoendoscopic Surgeons 2000;4(4):301-4.
References to studies excluded from this review Abet 2017 {published data only}
    1. Abet E, Orion F, Denimal F, Brau-Weber AG, Kerviler B, Jean MH, et al. Interest of using ropivacaine for outpatient laparoscopic cholecystectomy: prospective randomized trial. World Journal of Surgery 2017;41(3):687-92. [DOI: 10.1007/s00268-016-3797-2]
Ahmed 2008 {published data only}
    1. Ahmed BH, Ahmed A, Tan DF, Awad ZT, Al-Aali AY, Kilkenny J, et al. Post-laparoscopic cholecystectomy pain: effects of intraperitoneal local anesthetics on pain control - a randomized prospective double-blinded placebo-controlled trial. American Surgeon 2008;74(3):201-9.
Alexander 1997 {published data only}
    1. Alexander DJ. Randomized trial of periportal peritoneal bupivacaine for pain relief after laparoscopic cholecystectomy - reply. British Journal of Surgery 1997;84(5):730.
Allegri 2017 {published data only}
    1. Allegri M, Ornaghi M, Ferland CE, Bugada D, Meghani Y, Calcinati S, et al. Peritoneal nebulization of ropivacaine during laparoscopic cholecystectomy: dose finding and pharmacokinetic study. Pain Research & Management 2017;2017:4260702. [DOI: 10.1155/2017/4260702]
Alper 2014 {published data only}
    1. Alper I, Ulukaya S, Yuksel G, Uyar M, Balcioglu T. Laparoscopic cholecystectomy pain: effects of the combination of incisional and intraperitoneal levobupivacaine before or after surgery. Agri 2014;26(3):107-12. [DOI: 10.5505/agri.2014.42650]
Bayar 1998 {published data only}
    1. Bayar M, Ilhan Y, Onal A, Akkus M, Cifter C. Evaluation of postoperative analgesia and catecholamine levels in laparoscopic cholecystectomy after injection of intraperitoneal bupivacaine. Agri 1998;10(2):30-4.
Beqiri 2012 {published data only}
    1. Beqiri AI, Domi RQ, Sula HH, Zaimi EQ, Petrela EY. The combination of infiltrative bupivacaine with low-pressure laparoscopy reduces postcholecystectomy pain. A prospective randomized controlled study. Saudi Medical Journal 2012;33(2):134-8.
Berven 1995 {published data only}
    1. Berven S, Horvath K, Brooks DC. The effect of topical intraperitoneal bupivacaine on post-operative pain following laparoscopic cholecystectomy. Minimally Invasive Therapy 1995;4(2):67-71.
Bhattarai 2013 {published data only}
    1. Bhattarai PR, Bhattarai B, Sah BP, Adhikary S, Ghimire A. Comparison of analgesic effectiveness of combined intraperitoneal instillation and periportal infiltration of bupivacaine with intraperitoneal instillation or periportal infiltration alone after laparoscopic cholecystectomy. Regional Anesthesia and Pain Medicine 2013;38(1):A2.
Bisgaard 1999 {published data only}
    1. Bisgaard T, Klarskov B, Kristiansen VB, Callesen T, Schulze S, Kehlet H, et al. Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study. Anesthesia and Analgesia 1999;89(4):1017-24.
Busley 1999 {published data only}
    1. Busley R, Blobner M, Jelen-Esselborn S, Feussner H, Kochs E. Intraperitoneal local anaesthetics via subphrenic catheter following laparoscopic cholecystectomy: pain relief and pulmonary function. Minimally Invasive Therapy & Allied Technologies 1999;8(4):219-25.
Caliskan 2006 {published data only}
    1. Caliskan K, Nursal TZ, Yildirim S, Moray G, Torer N, Noyan T, et al. Hydrodissection with adrenaline-lidocaine-saline solution in laparoscopic cholecystectomy. Langenbeck's Archives of Surgery 2006;391(4):359-63. [DOI: 10.1007/s00423-006-0049-1]
Celik 2000 {published data only}
    1. Celik J, Tuncer S, Reisli R, Okesli S, Otelcioglu S. Intraperitoneal versus interpleural analgesia on post-operative pain to laparoscopic cholecystectomy. Turk Anesteziyoloji ve Reanimasyon 2000;28(6):317-21.
ChiCTR TRC 14005189 {published data only}
    1. ChiCTR-TRC-14005189. Efficacy of calot's triangle local infiltration with ropivacaine for postoperative pain in patients undergoing laparoscopic cholecystectomy: a prospective, randomized, double-blind, controlled, clinical trial. (First received 7 September 2014).
Choi 2014 {published data only}
    1. Choi YS, Gang H. Intraperitoneal and intravenous lidocaine for pain relief after laparoscopic cholecystectomy: a prospective randomized double-blind placebo-controlled study. Surgical Endoscopy and Other Interventional Techniques 2014;28:265. [DOI: 10.1007/s00464-014-3474-1]
CTRI201709009875 {published data only}
    1. CTRI/2017/09/009875. A study to compare efficacy of two types of pain relief methods i.e injection at the operation site in the skin versus putting the medicine in the abdominal cavity combined with injection at operation post operative pain relief and effect on recovery after laproscopic cholecystectomy. (First received 20 September 2017).
CTRI201802012070 {published data only}
    1. CTRI/2018/02/012070. Study to compare different analgesics to provide pain relief after laparoscopic gall bladder removal. (First received 22 February 2018).
CTRI201902017802 {published data only}
    1. CTRI/2019/02/017802. A clinical trial to study effect of bupivacaine for post operative pain in patients undergoing surgery for gall stone disease laparoscopically. (First received 25 February 2019).
Cunniffe 1998 {published data only}
    1. Cunniffe MG, McAnena OJ, Dar MA, Calleary J, Flynn N. A prospective randomized trial of intraoperative bupivacaine irrigation for management of shoulder-tip pain following laparoscopy. American Journal of Surgery 1998;176(3):258-61.
Delen 2018 {published data only}
    1. Delen LA, Disli ZK, Oba S. Comparison of effectiveness on postoperative pain and analgesic consumption of intraperitoneal levobupivacaine in laparoscopic cholecystectomy operations. Anestezi Dergisi 2018;26(3):180-6.
Di Pace 2009 {published data only}
    1. Di Pace MR, Cimador M, Catalano P, Caruso A, Sergio M, Casuccio A, et al. Efficacy of periportal infiltration and intraperitoneal instillation of ropivacaine after laparoscopic surgery in children. Journal of Laparoendoscopic & Advanced Surgical Techniques 2009;19(6):821-5.
Elhakim 2000a {published data only}
    1. Elhakim M, Elkott M, Ali NM, Tahoun HM. Intraperitoneal lidocaine for postoperative pain after laparoscopy. Acta Anaesthesiologica Scandinavica 2000;44(3):280-4.
Elhakim 2000b {published data only}
    1. Elhakim M, Amine H, Kamel S, Saad F. Effects of intraperitoneal lidocaine combined with intravenous or intraperitoneal tenoxicam on pain relief and bowel recovery after laparoscopic cholecystectomy. Acta Anaesthesiologica Scandinavica 2000;44(8):929-33.
EUCTR2008‐002029‐36‐IT {published data only}
    1. EUCTR2008-002029-36-IT. Impact of intraperitonael nebulization of local anesthetic on postoperative pain associated with laparoscopic cholecystectomy - ND. (First received 21 April 2008).
EUCTR2009‐012639‐13‐NL {published data only}
    1. EUCTR2009-012639-13-NL. Combined intracutaneous and intraperitoneal anaesthesia for postoperative pain reduction after laparoscopic cholecystectomy - Intense Trial. (First received 11 May 2009).
Futier 2011 {published data only}
    1. Futier E, Petit A, Pezet D. Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy (Br J Surg 2011; 98: 784-789). British Journal of Surgery 2011;98(8):1179; author reply 1179-80. [DOI: 10.1002/bjs.7633]
Gharaibeh 2000 {published data only}
    1. Gharaibeh KI, Al-Jaberi TM. Bupivacaine instillation into gallbladder bed after laparoscopic cholecystectomy: does it decrease shoulder pain? Journal of Laparoendoscopic & Advanced Surgical Techniques - Part A 2000;10(3):137-41.
Grünberg 2004 {published data only}
    1. Grünberg G, Noya B, Heuguerot F, Amestoy V, Basignani N, Baptista W, et al. Infiltrative analgesia in laparoscopic cholecystectomy [Analgesia infiltrativa en colecistectomia laparoscopica]. Anestesia Analgesia Reanimación 2004;19(1):13-20.
Gupta 2002 {published data only}
    1. Gupta A, Thörn SE, Axelsson K, Larsson LG, Agren G, Holmström B, et al. Postoperative pain relief using intermittent injections of 0.5% ropivacaine through a catheter after laparoscopic cholecystectomy. Anesthesia and Analgesia 2002;95(2):450-6.
Gvozdenovic 2015 {published data only}
    1. Gvozdenovic L, Ivanov D, Ivanov O. Levobupivacaine for local intraperitoneal anesthetics as a supplement to general anesthesia for laparoscopic surgery: a randomized double blind study. European Review for Medical and Pharmacological sciences 2015;19(11):1943-4.
Hernández‐Palazón 2003 {published data only}
    1. Hernández-Palazón J, Tortosa JA, Nuño de la Rosa V, Giménez-Viudes J, Ramírez G, Robles R. Intraperitoneal application of bupivacaine plus morphine for pain relief after laparoscopic cholecystectomy. European Journal of Anaesthesiology 2003;20(11):891-6.
Hilvering 2011 {published data only}
    1. Hilvering B, Draaisma WA, Bilt JD, Valk RM, Kofman KE, Consten EC. Randomized clinical trial of combined preincisional infiltration and intraperitoneal instillation of levobupivacaine for postoperative pain after laparoscopic cholecystectomy. British Journal of Surgery 2011;98(6):784-9.
Hwang 1998 {published data only}
    1. Hwang HY, Park HS, Lee SI, Hwang GB, Lee YW. The effects of intraperitoneal local anesthetics on the postoperative pain relief in laparoscopic cholecystectomy. Korean Journal of Anesthesiology 1998;34(2):413-7.
Inan 2004 {published data only}
    1. Inan A, Sen M, Dener C. Local anesthesia use for laparoscopic cholecystectomy. World Journal of Surgery 2004;28(8):741-4.
IRCT138810112946N1 {unpublished data only}
    1. IRCT138810112946N1. Effect of intraperitoneal bupivacaine on pain relief after laparoscopic cholecystectomy. (First received 25 May 2010).
IRCT2014020716516N1 {unpublished data only}
    1. IRCT2014020716516N1. The effect of intraperitoneal lidocaineand bupivacain on post operative pain in laparoscopic cholecystectomy compare with normal saline in patient who are undergoing laparoscopic cholecystectomy. (First received 12 August 2014).
IRCT2017012110222N7 {unpublished data only}
    1. IRCT2017012110222N7. Comparing the topical effect of bupivacaine and hydrocortisone in gallbladder bed on post operative pain following laparoscopic cholecystectomy among chronic cholecystitis patients. (First received 6 February 2017).
IRCT2017021632419N2 {published data only}
    1. IRCT2017021632419N2. The effect of washout of the surgery site with Marcaine or petedine on postoperative analgesia in patients with gallbladder. (First received 4 April 2017).
IRCT201703011264N9 {published data only}
    1. IRCT201703011264N9. Comparison of pain severity after intraperitoneal injection of bupivacaine, morphine, hydrocortisone in laparoscopic cholecystectomy. (First received 27 May 2017).
IRCT2017032733159N1 {published data only}
    1. IRCT2017032733159N1. Clinical trial comparing the effectiveness of intraperitoneal bupivacaine, acetazolamide and placebo on pain relief after laparoscopic cholecystectomy surgery. (First received 6 June 2017).
ISRCTN68753145 {unpublished data only}
    1. ISRCTN68753145. Prospective randomized trial to assess the efficacy of 0.5% Marcaine subserosal injection in the gall bladder fossa to reduce the post operative pain from laparoscopic cholecystectomy. (First received 29 September 2006).
ISRCTN80508655 {unpublished data only}
    1. ISRCTN80508655. Intraperitoneal levobupivacaine and dexamethasone for post-operative pain after laparoscopic cholecystectomy. (First received 30 September 2005).
Ivanovs 2013 {published data only}
    1. Ivanovs I, Mihelsons M, Boka V, Saba M. Preemptive gallbladder bed infiltration with local anaesthetics before gallbladder dissection in laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques 2013;27:S56. [DOI: 10.1007/s00464-013-2876-9]
Johnson 1999 {published data only}
    1. Johnson RC, Hedges AR, Morris R, Stamatakis JD. Ideal pain relief following laparoscopic cholecystectomy. International Journal of Clinical Practice 1999;53(1):16-8.
Kaushal‐Deep 2019 {published data only}
    1. Kaushal-Deep SM, Lodhi M, Anees A, Khan S, Khan MA. Randomised prospective study of using intraoperative, intraincisional and intraperitoneal ropivacaine for the early discharge of post-laparoscopic cholecystectomy patients as a day case in a cost-effective way in government setup of low-income and middle-income countries: opening new horizons. Postgraduate Medical Journal 2019;95(1120):78-84. [DOI: 10.1136/postgradmedj-2018-135662]
Khalili 2017 {published data only}
    1. Khalili G, Sadeghifar M, Attari MA. Evaluation of the effect of intravenous and intraperitoneal lidocaine on pain intensity in comparison to control group in laparoscopic cholecystectomy. Journal of Isfahan Medical School 2017;35(441):927-33.
Lauwick 2008 {published data only}
    1. Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, et al. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Canadian Journal of Anaesthesia 2008;55(11):754-60.
Lindgren 1997 {published data only}
    1. Lindgren L. Pain after laparoscopic cholecystectomy - do we do our best? Acta Anaesthesiologica Scandinavica 1997;41(2):191-2.
Logotheti 2012 {published data only}
    1. Logotheti E, Anagnostis G, Vekrakou A, Ifantidis F, Vlachos D, Mitrolios M. The efficacy of combined somatovisceral blockade with ropivacaine and morphine after laparoscopic cholecystectomy. European Journal of Anaesthesiology 2012;29(Suppl 50):205.
Mack 1995 {published data only}
    1. Mack P. Intraperitoneal local anesthetic after laparoscopic cholecystectomy. Journal of Laparoendoscopic Surgery 1995;5(5):343-4.
Maharjan 2009 {published data only}
    1. Maharjan SK, Shrestha S. Intraperitoneal and periportal injection of bupivacaine for pain after laparoscopic cholecystectomy. Kathmandu University Medical Journal 2009;7(25):50-3.
McDermott 2013 {published data only}
    1. McDermott AM, Chang KH, Mieske K, McAnena P, Kinirons B, Abeidi A, et al. Aerosolised intraperitoneal local anaesthetic (aila) for laparoscopic surgery: a randomised, double-blinded, placebo-controlled study. Irish Journal of Medical Science 2013;182:S42-3. [DOI: 10.1007/s11845-013-0908-z]
McDermott 2015 {published data only}
    1. McDermott AM, Chang KH, Mieske K, McAnena PF, Kinirons B, Abeidi A, et al. Aerosolized intraperitoneal local anesthetic for laparoscopic surgery: a randomized, double-blinded, placebo-controlled trial. World Journal of Surgery 2015;39(7):1681-9. [DOI: 10.1007/s00268-015-2973-0]
Memedov 2010 {published data only}
    1. Memedov C, Mentes O, Simsek A, Kece C, Yagci G, Harlak A, et al. Comparison of analgesic effects of intraperitoneal lornoxicam and ropivacaine administration in laparoscopic cholecystectomy. Trakya Universitesi Tip Fakultesi Dergisi 2010;27(2):142-9.
Michaloliakou 1996 {published data only}
    1. Michaloliakou C, Chung F, Sharma S. Preoperative multimodal analgesia facilitates recovery after ambulatory laparoscopic cholecystectomy. Anesthesia and Analgesia 1996;82(1):44-51.
Moreira 2000 {published data only}
    1. Moreira RW, Amatto PE, Bessa-Jr RC, Silva JB. Intraperitoneal bupivacaine for pain relief after laparoscopic cholecystectomy. Revista Brasileira de Anestesiologia 2000;50(4):283-8.
NCT00836316 {published data only}
    1. NCT00836316. Levobupivacaine during cholecystectomy. (First received 4 February 2009).
NCT01248819 {published data only}
    1. NCT01248819. Local anesthetic nebulization and instillation for pain control after laparoscopic surgery. (First received 25 November 2010).
NCT01972620 {published data only}
    1. NCT01972620. RCT: multi-modal analgesia for laparoscopic cholecystectomy. (First received 30 October 2013).
NCT02300480 {published data only}
    1. NCT02300480. Effects of calot's triangle block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy: a prospective, randomized, double-blind, controlled, clinical trial. (First received 25 November 2014).
NCT03708874 {published data only}
    1. NCT03708874. Pain management of emergency laparoscopic cholecystectomy in patients with acute cholecystitis. (First received 17 October 2018).
Newcomb 2007 {published data only}
    1. Newcomb W, Lincourt A, Hope W, Schmelzer T, Sing R, Kercher K, et al. Prospective, double-blinded, randomized, placebo-controlled comparison of local anesthetic and nonsteroidal anti-inflammatory drugs for postoperative pain management after laparoscopic surgery. American Surgeon 2007;73(6):618-24.
Ng 2002 {published data only}
    1. Ng A, Smith G. Intraperitoneal administration of analgesia: is this practice of any utility? British Journal of Anaesthesia 2002;89(4):535-7.
Özkoçak 2002 {published data only}
    1. Özkoçak I, Kirdemir P, Rasa K, Aksu C, Gögüs N. The comparison of preemptive intraperitoneal analgesic effects of tramadol, pethidine and bupivacaine. Anestezi Dergisi 2002;10(1):49-52.
Paech 2008 {published data only}
    1. Paech MJ, Ilett KF, Hackett LP, Page-Sharp M, Parsons RW. Disposition and clinical outcome after intraperitoneal meperidine and ropivacaine administration during laparoscopic surgery. Anesthesia and Analgesia 2008;106(1):278-86.
Papadima 2009 {published data only}
    1. Papadima A, Lagoudianakis EE, Antonakis P, Filis K, Makri I, Markogiannakis H, et al. Repeated intraperitoneal instillation of levobupivacaine for the management of pain after laparoscopic cholecystectomy. Surgery 2009;146(3):475-82.
Protic 2017 {published data only}
    1. Protic M, Veljkovic R, Bilchik AJ, Popovic A, Kresoja M, Nissan A, et al. Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy. Surgical Endoscopy and Other Interventional Techniques 2017;31(2):704-13. [DOI: 10.1007/s00464-016-5024-5]
Rahimzadeh 2018 {published data only}
    1. Rahimzadeh P, Faiz SHR, Hoseini M, Mousavie SH, Imani F, Negah AR. Comparison of intraperitoneal bupivacaine, acetazolamide, and placebo on pain relief after laparoscopic cholecystectomy surgery: a clinical trial. Medical journal of the Islamic Republic of Iran 2018;32:112. [DOI: 10.14196/mjiri.32.112]
Rizzotti 2002 {published data only}
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References to ongoing studies CTRI/2020/09/027799 {published data only}
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TCTR20190316001 {published data only}
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References to other published versions of this review Gurusamy 2008b
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Gurusamy 2011
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Gurusamy 2014a
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