Comparison of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine

August 19, 2024 updated by: Muhammad Aamir Latif, RESnTEC, Institute of Research

Comparison Between Mean Duration of Post-operative Analgesia of Intraperitoneal Bupivacaine Alone or With Dexmedetomidine Following Laparoscopic Cholecystectomy

For patients with symptomatic cholelithiasis, laparoscopic cholecystectomy (LC) is a customary procedure for treatment these days. After LC, patients may experience considerable pain. This study was performed with the objective of comparing the mean duration of analgesia of intraperitoneal bupivacaine with dexmedetomidine to intraperitoneal bupivacaine alone in patients undergoing laparoscopic cholecystectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

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
    • Punjab
      • Bahawalpur, Punjab, Pakistan, 06318
        • Quaid-E-Azam Medical College

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients of either gender
  • Aged between 20 and 70 years
  • ASA (American Society of Anesthesiologists Classification) physical status I and II
  • Undergoing Laparoscopic Cholecystectomy under general anesthesia

Exclusion Criteria:

  • Patients sensitive to local anesthetics
  • Patients with acute cholecystitis, choledocholithiasis, or ascending cholangitis (temperature≥38.6°C, serum bilirubin≥1.2mg/dl, and ultrasound showing common bile duct diameter of ≥1cm).
  • Patients with uncontrolled diabetes (FBS≥110 mg/dl)
  • Uncontrolled blood pressure (SBP≥140 mmHg)
  • Ischemic heart disease (EF≤40%)
  • Pulmonary dysfunction (FEV≤70 percent of normal)

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine group
Patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline
Drug: Bupivacaine injection
patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline.
Other Names:
  • Local anesthetic
Experimental: Bupivacaine + Dexmedetomidine group
Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml
Drug: Bupivacaine injection
patients received intraperitoneal bupivacaine 50 ml 0.25% + 5 ml normal saline.
Other Names:
  • Local anesthetic
Drug: Dexmedetomidine injection
Patients were given intraperitoneal bupivacaine 50 ml 0.25% + dexmedetomidine 1 μg/kg with normal saline 5 ml.
Other Names:
  • Local anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: 24 hours
The duration of postoperative analgesia was calculated as the time in minutes starting after the dressing of the patient in the operation room until the patient had a VAS≥3.
24 hours

Collaborators and Investigators

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

Sponsor

RESnTEC, Institute of Research

Collaborators

Bahawal Victoria Hospital

Investigators

  • Principal Investigator: Qazi Anees, FCPS, Bahawal Victoria Hospital
  • Principal Investigator: Syed Shakeel Ahmed, FCPS, Shahida Islam Teaching Hospital

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 (Actual)

January 1, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 15, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRQAZIANEESBVH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared with other researchers on a reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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