Intraperitoneal Analgesia After Laparoscopic Cholecystectomy

January 24, 2011 updated by: Aga Khan University

Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial

Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy.

If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

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

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy
  • Elective surgical procedure
  • American Society of Anesthesiologists class I and II

Exclusion Criteria:

  • Patients refusing randomization
  • Patients already on analgesics
  • Patients with acute cholecystitis
  • Patients requiring preoperative cholangiogram or common bile duct exploration
  • Patients having bile or stone spillage during procedure
  • Patients requiring conversion to open procedure
  • Patients requiring re-exploration for any reason
  • Patients with history of allergy to local anesthetic agents

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intraperitoneal lignocaine
Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy
Drug: lignocaine
200 mg of intraperitoneal lignocaine will be given once during surgery
Drug: bupevacaine
100 mg of bupevacaine will be given once during laparoscopic cholecystectomy
Active Comparator: intraperitoneal bupevacaine
intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy
Drug: lignocaine
200 mg of intraperitoneal lignocaine will be given once during surgery
Drug: bupevacaine
100 mg of bupevacaine will be given once during laparoscopic cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Control after Laparoscopic Cholecystectomy
Time Frame: 24 hours after surgery
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Requirement of Analgesia after laparoscopic cholecystectomy
Time Frame: 24 hours after surgery
24 hours after surgery

Collaborators and Investigators

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

Sponsor

Aga Khan University

Investigators

  • Principal Investigator: Muhammad R Khan, FRCS, Aga Khan University

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

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

July 31, 2009

First Submitted That Met QC Criteria

July 31, 2009

First Posted (Estimate)

August 3, 2009

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091026SUR

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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