Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425484
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Brief Title:
The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation
Sponsor:
Universiti Sains Malaysia
Organization:
Universiti Sains Malaysia
Study Overview
Official Title:
The Comparison of Effectiveness Between Epidural Combined Bilateral US TAP Block Versus Epidural Alone for Gynaecology Operation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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 005 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 01 fentanyl 2mcgml infusion for next 24hrs
The APS team will review patient post operatively in ward and all data will be recorded Participation of patients during study is approximately 2 days duration
Study size of 46 subjects based on repeated measure ANOVA between factor alpha value 005 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 01 fentanyl 2mcgml infusion for next 24hrs
The APS team will review patient post operatively in ward and all data will be recorded Participation of patients during study is approximately 2 days duration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None