RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy (LapChole)

October 24, 2013 updated by: Radovan Veljkovic, M.D., Ph.D., Klinicki Centar Vojvodine

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Klinicki centar Vojvodine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multi-modal analgesia
Thirty-one patients were enrolled in this arm. Standard analgesia according to institutional standard and 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 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, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the 4 laparoscopic port sites (2 ml per port site) prior sutured closure.
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
Other Names:
  • Marcaine
  • Bupivacaine HCL
No Intervention: Control
Thirty-two patients were enrolled in this arm. They received standard analgesia according to institutional standard of practice consisted of non-narcotic analgesia with narcotic analgesic rescue after laparoscopic cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Scale Pain VAS
Time Frame: from 0 to 7 postoperative days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nausea
Time Frame: from 0 to 6 hours post-operatively
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
mobility
Time Frame: from 0 to 7 postoperative days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinicki Centar Vojvodine

Investigators

  • Principal Investigator: Radovan Veljkovic, MD, PhD, Clinical Centre of Vojvodina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-01/515

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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