Clinical trial NCT01972620: RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy
Official title: Prospective Randomized Controlled Trial (PRCT) Comparing Standard Analgesia With Multi-modal Targeted Operative and Port-Site Local Anesthesia for Post-Operative Pain Management in Elective Laparoscopic Cholecystectomy (LapChole)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gallstones
Cholelithiasis
Pain
Keywords: gallstones
cholelithiasis
cholecystectomy, laparoscopic
pain
Lead sponsor: Klinicki Centar Vojvodine
Sponsor class: OTHER
First posted: 2013-10-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after laparoscopic cholecystectomy.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Scale Pain VAS
timeFrame: from 0 to 7 postoperative days
Secondary outcomes:
measure: nausea
timeFrame: from 0 to 6 hours post-operatively
Other outcomes:
measure: mobility
timeFrame: from 0 to 7 postoperative days
Locations:
city: Novi Sad
country: Serbia
facility: Klinicki Centar Vojvodine
state: Vojvodina
Study officials:
affiliation: Clinical Centre of Vojvodina
name: Radovan Veljkovic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Surg Endosc. 2006 Oct;20(10):1560-4. doi: 10.1007/s00464-005-0284-5. Epub 2006 Aug 1.
citation: Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg. 2006 Sep;103(3):682-8. doi: 10.1213/01.ane.0000226268.06279.5a.
citation: Mitra S, Khandelwal P, Roberts K, Kumar S, Vadivelu N. Pain relief in laparoscopic cholecystectomy--a review of the current options. Pain Pract. 2012 Jul;12(6):485-96. doi: 10.1111/j.1533-2500.2011.00513.x. Epub 2011 Oct 19.
citation: Gupta A. Local anaesthesia for pain relief after laparoscopic cholecystectomy--a systematic review. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):275-92. doi: 10.1016/j.bpa.2004.12.007.