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Clinical Trials/NCT05264805
NCT05264805
Unknown
Phase 3

A Randomized Controlled Trial of Port Site Subcutaneous Injection of Bupivacaine to Determine the Effectiveness of Postoperative Pain Relief After Laparoscopic Cholecystectomy

Hamdard University0 sites166 target enrollmentMarch 2022

Overview

Phase
Phase 3
Intervention
0.25% Bupivacaine
Conditions
Pain, Postoperative
Sponsor
Hamdard University
Enrollment
166
Primary Endpoint
Post laparoscopic port site pain assessment
Last Updated
4 years ago

Overview

Brief Summary

To determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Detailed Description

The study is being done to determine the effectiveness of port site bupivacaine infiltration in postoperative pain reduction after laparoscopic cholecystectomy.

Registry
clinicaltrials.gov
Start Date
March 2022
End Date
September 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Nida Shahid

Assistant Professor

Hamdard University

Eligibility Criteria

Inclusion Criteria

  • Patients of both the gender of age \>18 years and \<45years
  • Patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
  • Patients with A.S.A grade I and II.

Exclusion Criteria

  • Patients with known allergic reactions to local anesthetics.
  • Patients converted to open procedure.
  • Patients developing intra-operative complications.
  • Patients undergoing for laparoscopic cholecystectomy for acute cholecystitis.
  • Patients with obesity and chronic illness.
  • Patients with history of opioids, steroids, NSAIDs and alcohol use.

Arms & Interventions

Bupivacaine group

Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site

Intervention: 0.25% Bupivacaine

Outcomes

Primary Outcomes

Post laparoscopic port site pain assessment

Time Frame: Pain assessment from 0hour (patient received in recovery room) till 12hours postoperatively at interval of 3hours i.e. 0,3,6,9,12 hour

Pain assessment by "Visual Analog Scoring system" scoring from 0 to 10, where 0 means no pain and 10 means worst possible, unbearable excruciating pain.

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