The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation.

May 17, 2024 updated by: Rhendra Hardy Mohamad Zaini, Universiti Sains Malaysia

The goal of this clinical trial is to compare effectiveness between epidural combined with TAP block versus epidural alone in gynaecology operation participant .The main question[s] it aims to answer are:

  • what is the pain score for both groups
  • what is the requirement of epidural infusion between the 2 groups Participants will be given general anesthesia for the operation with the epidural insertion prior to induction. Patient will be randomized into epidural plus TAP block or epidural alone for the study. The US TAP block will be given at the end of operation prior to extubation.

Researchers will compare pain score, epidural infusion requirment between the two groups.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The research is a prospective randomized control study. It is blinded study as accessor is blinded whereby the acute pain service (APS) team will be reviewing patient postoperatively.

Study size of 46 subjects based on repeated measure ANOVA between factor , alpha value 0.05% with 80% power study, a dropout 10%. Divided into 2 groups ; Group E - epidural alone, Group T - epidural plus bilateral US TAP block.

Perioperatively, epidural catheter will be inserted then induction for general anesthesia given. Intraoperatively anesthesia maintain with inhalation agent. Prior to extubation, bilateral TAP block is provided using portable US guidance. At this location, the 3 layers of anterior abdominal wall is visualized for the truncal block. Post operatively, participant will be given epidural cocktail bupivacaine 0.1% + fentanyl 2mcg/ml infusion for next 24hrs.

The APS team will review patient post operatively in ward and all data will be recorded. Participation of patient's during study is approximately 2 days duration.

Study Type

Interventional

Enrollment (Estimated)

46

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 Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150

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:

  • Elective major laparotomy gynaecology procedure.
  • Age 18 years and above
  • ASA I, II, III

Exclusion Criteria:

  • Prolonged INR
  • Allergic to LA
  • History of chronic pain
  • Psychological disorder/addict to opioid or benzodiazepine
  • Any contraindication for epidural or TAP block procedure
  • Pregnancy

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group T
Group epidural with bilateral US TAP block
Other: Bilateral US TAP block
epidural plus bilateral US guided TAP block
Active Comparator: Group E
Group epidural alone
Other: Bilateral US TAP block
epidural plus bilateral US guided TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score between epidural plus bilateral TAP block and epidural alone
Time Frame: Post operatively, until day 2 post operation.
To compare the pain score between 2 groups (epidural with bilateral TAP block) and epidural alone for gynaecology operation.
Post operatively, until day 2 post operation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)
Time Frame: Post operatively, until day 2 post operation.
To compare the postoperative epidural infusion requirement between bilateral US guided TAP block plus epidural versus epidural alone.
Post operatively, until day 2 post operation.
To evaluate time of early mobilization between 2 groups ( Group T and Group E)
Time Frame: Post operatively, until day 2 post operation.
To evaluate time taken for early mobilization between group Epidural with TAP block and epidural alone after the operation .
Post operatively, until day 2 post operation.

Collaborators and Investigators

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

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Munirah Abdul Majid, University Sains Malaysia
  • Study Director: W.Mohd Nazaruddin W. Hassan, University Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 31, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

May 17, 2024

First Submitted That Met QC Criteria

May 17, 2024

First Posted (Actual)

May 22, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USM/JEPeM/kk/23010129

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.

Clinical Trials on Gynecologic Disease

Clinical Trials on Bilateral US TAP block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe