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Meta-Analysis
. 2014 Mar 25;2014(3):CD009060.
doi: 10.1002/14651858.CD009060.pub2.

Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy

Kurinchi Selvan Gurusamy  1 , Myura Nagendran, Clare D Toon, Gian Piero Guerrini, Murat Zinnuroglu, Brian R Davidson
Affiliations
Meta-Analysis

Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy

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

Abstract

Background: Intraperitoneal local anaesthetic instillation may decrease pain in people undergoing laparoscopic cholecystectomy. However, the optimal method to administer the local anaesthetic is unknown.

Objectives: To determine the optimal local anaesthetic agent, the optimal timing, and the optimal delivery method of the local anaesthetic agent used for intraperitoneal instillation 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 for assessment of benefit and comparative non-randomised studies for the assessment of treatment-related harms.

Selection criteria: We considered only randomised clinical trials (irrespective of language, blinding, or publication status) comparing different methods of local anaesthetic intraperitoneal instillation during laparoscopic cholecystectomy for the 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 12 trials with 798 participants undergoing elective laparoscopic cholecystectomy randomised to different methods of intraperitoneal local anaesthetic instillation. All the trials were at high risk of bias. Most trials included only people with low anaesthetic risk. The comparisons included in the trials that met the eligibility criteria were the following; comparison of one local anaesthetic agent with another local anaesthetic agent (three trials); comparison of timing of delivery (six trials); comparison of different methods of delivery of the anaesthetic agent (two trials); comparison of location of the instillation of the anaesthetic agent (one trial); three trials reported mortality and morbidity.There were no mortalities or serious adverse events in either group in the following comparisons: bupivacaine (0/100 (0%)) versus lignocaine (0/106 (0%)) (one trial; 206 participants); just after creation of pneumoperitoneum (0/55 (0%)) versus end of surgery (0/55 (0%)) (two trials; 110 participants); just after creation of pneumoperitoneum (0/15 (0%)) versus after the end of surgery (0/15 (0%)) (one trial; 30 participants); end of surgery (0/15 (0%)) versus after the end of surgery (0/15 (0%)) (one trial; 30 participants).None of the trials reported quality of life, the time taken to return to normal activity, or the time taken to return to work. The differences in the proportion of people who were discharged as day-surgery and the length of hospital stay were imprecise in all the comparisons included that reported these outcomes (very low quality evidence). There were some differences in the pain scores on the visual analogue scale (1 to 10 cm) but these were neither consistent nor robust to fixed-effect versus random-effects meta-analysis or sensitivity analysis.

Authors' conclusions: The currently available evidence is inadequate to determine the effects of one method of local anaesthetic intraperitoneal instillation compared with any other method of local anaesthetic intraperitoneal instillation in low anaesthetic risk individuals undergoing elective laparoscopic cholecystectomy. 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.

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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 mortality (just after creation of pneumoperitoneum versus end of surgery) 
 The diversity‐adjusted required information size (DARIS) was calculated to 352,564 participants, based on the proportion of participants in the control group with the outcome of 0.2%, 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 110 participants in two trials, only 0.03% 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 morbidity (just after creation of pneumoperitoneum versus end of surgery) 
 The diversity‐adjusted required information size (DARIS) was calculated to 34,685 participants, based on the proportion of participants in the control group with the outcome of 2%, 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 110 participants in two trials, only 0.32% 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.
6
6
Trial sequential analysis of pain (4 to 8 hours) (just after creation of pneumoperitoneum versus end of surgery) 
 The diversity‐adjusted required information size (DARIS) was 563 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 7.09, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 60.45%. After accruing 84 participants in two trials, only 14.92% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the futility area. Neither the conventional statistical boundaries (dotted red line) or the trial sequential monitoring boundaries (continuous red line) for benefits or harms of just after creation of pneumoperitoneum versus end of surgery were crossed by the cumulative Z curve (blue line).
7
7
Trial sequential analysis of pain (4 to 8 hours) (aerosol versus liquid) 
 The diversity‐adjusted required information size (DARIS) was 17,109 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 6.3, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 98.34%. After accruing 97 participants in two trials, only 0.58% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the trial sequential monitoring boundaries or the information size. Although the conventional statistical boundaries (dotted red line) is crossed by the cumulative Z‐curve (blue line) favouring aerosol, the conventional statistical boundaries were not crossed when the random‐effects model was used.
8
8
Trial sequential analysis of pain (9 to 24 hours) (just after creation of pneumoperitoneum versus end of surgery) 
 The diversity‐adjusted required information size (DARIS) was 612 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 4.79, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 75.35%. After accruing 84 participants in two trials, only 13.72% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the futility area. Neither the conventional statistical boundaries (dotted red line) or the trial sequential monitoring boundaries (continuous red line) for benefits or harms of just after creation of pneumoperitoneum versus end of surgery were crossed by the cumulative Z curve (blue line).
9
9
Trial sequential analysis of pain (9 to 24 hours) (aerosol versus liquid) 
 The diversity‐adjusted required information size (DARIS) was 9847 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 3.68, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 98.82%. After accruing 97 participants in two trials, only 1.02% of the DARIS has been reached. Accordingly, the trial sequential analysis does not show the trial sequential monitoring boundaries or the information size. Although the conventional statistical boundaries (dotted red line) is crossed by the cumulative Z‐curve (blue line) favouring aerosol, the conventional statistical boundaries were not crossed when the random‐effects model was used.
1.1
1.1. Analysis
Comparison 1 Intervention versus control, Outcome 1 Proportion discharged as day‐surgery.
1.2
1.2. Analysis
Comparison 1 Intervention versus control, Outcome 2 Hospital stay.
1.3
1.3. Analysis
Comparison 1 Intervention versus control, Outcome 3 Pain 4 to 8 hours.
1.4
1.4. Analysis
Comparison 1 Intervention versus control, Outcome 4 Pain 9 to 24 hours.
See this image and copyright information in PMC

Update of

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References to other published versions of this review

Gurusamy 2008c
    1. Gurusamy KS, Guerrini GP, Zinnuroglu M, Davidson BR. Intra‐peritoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database of Systematic Reviews 2008, Issue 3. [DOI: 10.1002/14651858.CD007337] - DOI - PMC - PubMed

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