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

Universiti Sains Malaysia

Status: Enrolling

Conditions: Gynecologic Disease

Treatments: Other: Bilateral US TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT06425484

USM/JEPeM/kk/23010129

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Group T

Experimental group

Description:

Group epidural with bilateral US TAP block

Treatment:

Other: Bilateral US TAP block

Group E

Active Comparator group

Description:

Group epidural alone

Treatment:

Other: Bilateral US TAP block