RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy

Pain Clinical Trial

— LapChole  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972620
• Other study ID #: 00-01/515
• Status: Completed
• Phase: N/A
• First received: October 16, 2013
• Last updated: October 24, 2013
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2013
• Source: Klinicki Centar Vojvodine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Pain

Intervention

Drug:
• Bupivacaine
A 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen in the Multi-modal analgesia group, 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, again within the Multi-modal analgesia group, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the four laparoscopic port sites (2 ml per port site) prior to standard sutured closure of each incision

Locations

Country	Name	City	State
Serbia	Klinicki Centar Vojvodine	Novi Sad	Vojvodina

Sponsors (1)

Lead Sponsor	Collaborator
Klinicki Centar Vojvodine

Country where clinical trial is conducted

Serbia, 

References & Publications (4)

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. Review. — View 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. Review. — View 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. Review. — View 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. Epub 2006 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	mobility	Surgical outcome data recorded prospectively also included hospital stay (days), impairment of mobility [measured with VAS, 0 is worst and 10 optimal mobility (pre-operative baseline)] one and seven days post-operatively,	from 0 to 7 postoperative days	No
Primary	Visual Scale Pain VAS	The primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 7 days following laparoscopic cholecystectomy using the Visual Acuity Score (VAS, 0-10).	from 0 to 7 postoperative days	No
Secondary	nausea	Surgical outcome data recorded prospectively also included severity of post-operative nausea (measured VAS, 0 none and 10 worst state) on one and six hours post-operatively.	from 0 to 6 hours post-operatively	No