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

March 2, 2022 updated by: Dr. Nida Shahid, Hamdard University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

166

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine group
Patient receiving 20ml of inj. 0.25% Bupivacaine at laparoscopic port site
Drug: 0.25% Bupivacaine
20ml of 0.25% Bupivacaine subcutaneous infiltration at port site wound.
Other Names:
  • Bupivacain
No Intervention: Placebo group
No drug infiltration at laparoscopic port site

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Hamdard 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 (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N0333

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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