Gynecologic Disease
Conditions
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.
Interventions
OTHERBilateral US TAP block
epidural plus bilateral US guided TAP block
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
APS team will be assessing participants pain score in the ward and documented the data.
Intervention model description
Total sample size of 46 subjects, divided into 2 groups epidural alone (Group E) and epidural with bilateral US TAP block (Group T)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 . |
Countries
Malaysia
Contacts
Primary ContactRhendra Hardy Mohd Zain
Backup ContactSuki Ismet
Outcome results
None listed