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

  1. Kurinchi Selvan Gurusamy1,*,
  2. Myura Nagendran2,
  3. Gian Piero Guerrini3,
  4. Clare D Toon4,
  5. Murat Zinnuroglu5,
  6. Brian R Davidson1

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 13 MAR 2014

Assessed as up-to-date: 14 MAR 2013

DOI: 10.1002/14651858.CD007337.pub3


How to Cite

Gurusamy KS, Nagendran M, Guerrini GP, Toon CD, Zinnuroglu M, Davidson BR. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD007337. DOI: 10.1002/14651858.CD007337.pub3.

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

    Ravenna Hospital, Department of Surgery, Ravenna, Italy

  4. 4

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

  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: 13 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 mortalityThe 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 446 participants in eight trials, only 0.13% 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 morbidityThe 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 446 participants in eight trials, only 1.29% 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 proportion discharged as day surgeryThe diversity-adjusted required information size (DARIS) was calculated to 1,419,571 participants, based on the proportion of participants in the control group with the outcome of 48.78%, a relative risk reduction of 20%, an alpha of 5%, a beta of 20%, and a diversity of 99.94%. To account for zero event groups (or groups in which all the participants were discharged as day surgery), a continuity correction of 0.01 was used in the calculation of the cumulative Z-curve (blue line). After accruing 242 participants in three trials, only 0.02% 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 7]
Figure 7. Trial sequential analysis of length of hospital stayThe diversity-adjusted required information size (DARIS) was 107 participants based on a minimal relevant difference (MIRD) of 1 day, a variance (VAR) of 3.39, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 0%. After accruing 335 participants in five 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 (dotted red 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.
[Figure 8]
Figure 8. Trial sequential analysis of pain (4 to 8 hours)The diversity-adjusted required information size (DARIS) was 796 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 3.19, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 87.32%. The conventional statistical boundaries (dotted red 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 seventeenth 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.
[Figure 9]
Figure 9. Trial sequential analysis of pain (9 to 24 hours)The diversity-adjusted required information size (DARIS) was 580 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 2.06, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D2) of 88.81%. The conventional statistical boundaries (dotted red line) are crossed by the cumulative Z-curve (blue line) after the fifth trial . All the trial sequential monitoring boundaries (red line) are crossed by cumulative Z-curve after the twelfth 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.
[Analysis 1.1]
Analysis 1.1. Comparison 1 Local anaesthetic versus no local anaesthetic, Outcome 1 Mortality.
[Analysis 1.2]
Analysis 1.2. Comparison 1 Local anaesthetic versus no local anaesthetic, Outcome 2 Serious adverse events.
[Analysis 1.3]
Analysis 1.3. Comparison 1 Local anaesthetic versus no local anaesthetic, Outcome 3 Proportion discharged as day surgery.
[Analysis 1.4]
Analysis 1.4. Comparison 1 Local anaesthetic versus no local anaesthetic, Outcome 4 Hospital stay.
[Analysis 1.5]
Analysis 1.5. Comparison 1 Local anaesthetic versus no local anaesthetic, Outcome 5 Pain (4 to 8 hours).
[Analysis 1.6]
Analysis 1.6. Comparison 1 Local anaesthetic versus no local anaesthetic, Outcome 6 Pain (9 to 24 hours).
[Analysis 2.1]
Analysis 2.1. Comparison 2 Sensitivity analysis, Outcome 1 Proportion discharged as day surgery.
[Analysis 2.2]
Analysis 2.2. Comparison 2 Sensitivity analysis, Outcome 2 Hospital stay.
[Analysis 2.3]
Analysis 2.3. Comparison 2 Sensitivity analysis, Outcome 3 Pain (4 to 8 hours) (studies with imputed values removed).
[Analysis 2.4]
Analysis 2.4. Comparison 2 Sensitivity analysis, Outcome 4 Pain (9 to 24 hours) (studies with imputed values removed).
[Analysis 3.1]
Analysis 3.1. Comparison 3 Subgroup analysis, Outcome 1 Pain (4 to 8 hours) by local anaesthetic.
[Analysis 3.2]
Analysis 3.2. Comparison 3 Subgroup analysis, Outcome 2 Pain (4 to 8 hours) by dose.
[Analysis 3.3]
Analysis 3.3. Comparison 3 Subgroup analysis, Outcome 3 Pain (4 to 8 hours) by form.
[Analysis 3.4]
Analysis 3.4. Comparison 3 Subgroup analysis, Outcome 4 Pain (4 to 8 hours) by time.
[Analysis 3.5]
Analysis 3.5. Comparison 3 Subgroup analysis, Outcome 5 Pain (4 to 8 hours) by location.
[Analysis 3.6]
Analysis 3.6. Comparison 3 Subgroup analysis, Outcome 6 Pain (4 to 8 hours) by norepinephrine use.
[Analysis 3.7]
Analysis 3.7. Comparison 3 Subgroup analysis, Outcome 7 Pain (4 to 8 hours) by control.
[Analysis 3.8]
Analysis 3.8. Comparison 3 Subgroup analysis, Outcome 8 Pain (4 to 8 hours) by wound infiltration.
[Analysis 3.9]
Analysis 3.9. Comparison 3 Subgroup analysis, Outcome 9 Pain (4 to 8 hours) by routine supplemental analgesia.
[Analysis 3.10]
Analysis 3.10. Comparison 3 Subgroup analysis, Outcome 10 Pain (9 to 24 hours) by local anaesthetic.
[Analysis 3.11]
Analysis 3.11. Comparison 3 Subgroup analysis, Outcome 11 Pain (9 to 24 hours) by dose.
[Analysis 3.12]
Analysis 3.12. Comparison 3 Subgroup analysis, Outcome 12 Pain (9 to 24 hours) by form.
[Analysis 3.13]
Analysis 3.13. Comparison 3 Subgroup analysis, Outcome 13 Pain (9 to 24 hours) by time.
[Analysis 3.14]
Analysis 3.14. Comparison 3 Subgroup analysis, Outcome 14 Pain (9 to 24 hours) by location.
[Analysis 3.15]
Analysis 3.15. Comparison 3 Subgroup analysis, Outcome 15 Pain (9 to 24 hours) by norepinephrine use.
[Analysis 3.16]
Analysis 3.16. Comparison 3 Subgroup analysis, Outcome 16 Pain (9 to 24 hours) by control.
[Analysis 3.17]
Analysis 3.17. Comparison 3 Subgroup analysis, Outcome 17 Pain (9 to 24 hours) by wound infiltration.
[Analysis 3.18]
Analysis 3.18. Comparison 3 Subgroup analysis, Outcome 18 Pain (9 to 24 hours) by routine supplemental analgesia.