Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy

July 24, 2024 updated by: Dr Muhammad Arif

Transverses Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Pain Management in Patients Undergoing Total Abdominal Hysterectomy

To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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
        • Muhammad Arif

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age range 18 to 50 years
  • Female
  • ASA I & II
  • Undergoing Abdominal Hysterectomy under General anaesthesia

Exclusion Criteria:

  • Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)
  • Allergy or contraindication to study drugs on history
  • Drug abuse or addiction
  • Bleeding tendency

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transverses abdominis plane block
Procedure: Transverses Abdominis Plane Block
Transverses abdominis plane block will be provided randomly using prospective double-blinding.
Active Comparator: Local wound infiltration
Procedure: Local wound infiltration
Local wound infiltration will be provided randomly using prospective double-blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 24 hours of surgery.
Pain score will be evaluated through Visual analogue scale (VAS) score of 0-10cms.
24 hours of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesia consumption
Time Frame: During 24 hours of surgery
Patients will be given analgesics only on complain of pain of VAS score of 4 and above.
During 24 hours of surgery

Collaborators and Investigators

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

Sponsor

Dr Muhammad Arif

Investigators

  • Principal Investigator: Muhammad Arif, Ziauddin 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 (Actual)

December 1, 2023

Primary Completion (Actual)

February 28, 2024

Study Completion (Actual)

February 28, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7861023MAANE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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