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

Not Applicable

Recruiting

• Conditions: Gynecologic Disease
• Interventions: Other: Bilateral US TAP block

• Registration Number: NCT06425484
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

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.

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 Timeline

• Study Start: 2023-05-31
• Status Verified: 2024-05
• Study First Submitted: 2024-05-17
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Bilateral US TAP block	Group epidural alone
Group T	Bilateral US TAP block	Group epidural with bilateral US TAP block

Primary Outcome Measures

Name	Time	Method
Pain score between epidural plus bilateral TAP block and epidural alone	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.

Secondary Outcome Measures

Name	Time	Method
To compare the epidural infusion requirement between the 2 groups ( Group T and Group E)	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.
To evaluate time of early mobilization between 2 groups ( Group T and Group E)	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 .

Trial Locations

Locations (1)

Universiti Sains Malaysia; 🇲🇾 Kubang Kerian, Kelantan, Malaysia