Effectiveness of Port Site Bupivacaine Injection in Postoperative Pain Reduction After Lap. Chole

Phase 3

• Conditions: Pain, Postoperative
• Interventions: Drug: 0.25% Bupivacaine

• Registration Number: NCT05264805
• Lead Sponsor: Hamdard University

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.

Study Timeline

• Study First Submitted: 2022-02-04
• Status Verified: 2022-03
• Study Start: 2022-03
• Study First Submitted QC: 2022-03-02
• Last Update Submitted: 2022-03-02
• Study First Posted: 2022-03-03
• Last Update Posted: 2022-03-03
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine group	0.25% Bupivacaine	Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site

Primary Outcome Measures

Name	Time	Method
Post laparoscopic port site pain assessment	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.