RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy

Background: Peri-portal nerve stimulation has recently been suggested as a mechanism for pain after laparoscopic cholecystectomy (LapChole). We therefore conducted a PRCT to evaluate whether somatovisceral pain blockade reduces pain after LapChole.

Hypothesis:Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective LapChole for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site infiltrationwith0.25% bupivacaine significantly reduces pain after LapChole.

Design: Single-blinded PRCT Setting: Academic medical centers Patients and Methods: Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to institutional standard non-opioid/opioid analgesic combinations (n=32), and institutional standard analgesia plus topical 0.25%bupivacaine spray onto the cystic plate and local 0.25% bupivacaine port-site injection,post-LapChole (n=31). Primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 1 week post-LapCholeusing the Visual Acuity Score (VAS, 0-10).

Results: Study groups were comparable clinicopathologically. There were no study-procedure-associated adverse events. A statistically significant reduction in mean pain score was apparent in patients receiving multi-modal analgesia at all early (1-6 hours) post-operative time points and at one week following LapChole(p<0.05).

Conclusion: This PRCT shows significantly improved pain reduction with somatovisceral pain blockade than institutional standard analgesic combinations following LapChole for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for this operation, this multi-modal analgesic approach can improve patient comfort during recovery.This approach serves as the basis for a planned 4-arm PRCT designed to provide further insights into the role of local anesthetics in multi-modal operative site analgesia.

Inclusion criteria

• symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy
• non - pregnant women
• 18 years or older

Exclusion criteria

• undergoing urgent cholecystectomy
• patients operated on for indications other than symptomatic cholelithiasisT
• those having conversion from laparoscopic to open cholecystectomy
• those that withdrew from the study for any reason before the end of the required 7-day follow up (including those that died during that period)
• those with incomplete data.