Intervention Review

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Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy

  1. Kurinchi Selvan Gurusamy1,*,
  2. Myura Nagendran2,
  3. Clare D Toon3,
  4. Gian Piero Guerrini4,
  5. Murat Zinnuroglu5,
  6. Brian R Davidson1

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 25 MAR 2014

Assessed as up-to-date: 14 MAR 2013

DOI: 10.1002/14651858.CD009060.pub2


How to Cite

Gurusamy KS, Nagendran M, Toon CD, Guerrini GP, Zinnuroglu M, Davidson BR. Methods of intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD009060. DOI: 10.1002/14651858.CD009060.pub2.

Author Information

  1. 1

    Royal Free Campus, UCL Medical School, Department of Surgery, London, UK

  2. 2

    Department of Surgery, UCL Division of Surgery and Interventional Science, London, UK

  3. 3

    West Sussex County Council, Public Health, Chichester, West Sussex, UK

  4. 4

    Ravenna Hospital, Department of Surgery, Ravenna, Italy

  5. 5

    Physical Medicine and Rehabilitation/Algology and Clinical Neurophysiology, Gazi University Medical Faculty, Ankara, Turkey

*Kurinchi Selvan Gurusamy, Department of Surgery, Royal Free Campus, UCL Medical School, Royal Free Hospital, Rowland Hill Street, London, NW3 2PF, UK. k.gurusamy@ucl.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 25 MAR 2014

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[Figure 1]
Figure 1. Study flow diagram.
[Figure 2]
Figure 2. Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
[Figure 3]
Figure 3. Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
[Figure 4]
Figure 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.
[Figure 5]
Figure 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.
[Figure 6]
Figure 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).
[Figure 7]
Figure 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.
[Figure 8]
Figure 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).
[Figure 9]
Figure 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.
[Analysis 1.1]
Analysis 1.1. Comparison 1 Intervention versus control, Outcome 1 Proportion discharged as day-surgery.
[Analysis 1.2]
Analysis 1.2. Comparison 1 Intervention versus control, Outcome 2 Hospital stay.
[Analysis 1.3]
Analysis 1.3. Comparison 1 Intervention versus control, Outcome 3 Pain 4 to 8 hours.
[Analysis 1.4]
Analysis 1.4. Comparison 1 Intervention versus control, Outcome 4 Pain 9 to 24 hours.