| CTRI Number |
CTRI/2025/04/084471 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TO STUDY THE DURATION OF POSTOPERATIVE PAIN RELIEF PROVIDED BY NERVE BLOCKS IN PATIENTS UNDERGOING CESAREAN SECTION UNDER SUBARACHNOID BLOCK |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY TO EVALUATE THE ANALGESIC EFFICACY OF ULTRASOUND GUIDED TRANSVERSALIS FASCIA PLANE (TFP) BLOCK VS TRANSVERSUS ABDOMINIS PLANE (TAP) BLOCK IN CESAREAN SECTION UNDER SUBARACHNOID BLOCK |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suvina |
| Designation |
Associate Professor in Department of Anaesthesiology |
| Affiliation |
DR.B.R AMBEDKHAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Major OT Complex, 1st floor, Dr. B.R Ambedkar Medical college and hospital Shampura mainroad K.G.HALLI
Bangalore
KARNATAKA
560045
India |
| Phone |
6366279888 |
| Fax |
|
| Email |
suvi11492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suvina |
| Designation |
Associate Professor in Department of Anaesthesiology |
| Affiliation |
DR.B.R AMBEDKHAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Major OT Complex, 1st floor, Dr. B.R Ambedkar Medical college and hospital Shampura mainroad K.G.HALLI
KARNATAKA
560045
India |
| Phone |
6366279888 |
| Fax |
|
| Email |
suvi11492@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Merin Varghese |
| Designation |
Assistant Professor in Department of Anaesthesiology |
| Affiliation |
Dr. B.R Ambedkar Medical College and Hospital |
| Address |
Major OT Complex, 1st floor, Dr. B.R Ambedkar Medical College and Hospital,Shampura mainroad K.G.HALLI
Bangalore
KARNATAKA
560045
India |
| Phone |
918547502337 |
| Fax |
|
| Email |
merinvv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B.R Ambedkar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suvina |
Dr. B.R Ambedkar Medical College and Hospital |
Major OT complex, shampura mainroad K.G.HALLI, 560045
Bangalore
KARNATAKA |
6366279888
suvi11492@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Transversalis fascia plane block |
Ultrasound guided bilateral Transversalis fascia plane block with 20ml of 0.25% Bupivacaine and 4mg Dexmethasone on each side will be given as post-operative analgesia in patients undergoing cesarean section under subarachnoid block |
| Comparator Agent |
Bilateral Transversus abdominis plane block |
Ultrasound guided bilateral Transversus abdominis plane block with 20ml of 0.25% Bupivacaine and 4mg Dexmethasone on each side will be given as post-operative analgesia in patients undergoing cesarean section under subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing cesarean section under subarachnoid block
ASA - PS ( American Society of Anesthesiologists physical status) II & III |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post operative analgesic efficacy of transversalis fascia plane (TFP) block and transverse abdominis plane (TAP) block in cesarean section under subarachnoid block (total duration of blockade , time for 1st rescue analgesic ) |
Every 2nd hourly for 24hours in post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative VAS scores at 0,2,4,6,12, 24 hours
Post operative additional analgesic requirement in 24 hours.
Patient satisfaction scores.
Complications if any (LAST, PONV, hematoma at injection site, paresthesia, etc,. |
Every 2nd hourly for 24hours in post-operative period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pain after cesarean section (CS)has both a somatic component due to surgical incision and a visceral component due to uterine contractions. The sensory innervations of the Pfannenstiel incision in CS is provided by T 12 and L1 nerves branches including the lateral femoral cutaneous nerve, ilioinguinal and iliohypogastric nerve. Transversalis Fascia Plane (TFP) block involves injection of local anesthetic into this plane, thus providing targeted pain relief by blocking the nerves. TFP block targets ilioinguinal and iliohypogastric nerve, proximal branches of T12 and L1 and to a lesser extent T11. Transversus abdominis plane (TAP) block is among the most common techniques used and extensively studied for postoperative analgesia, it blocks T6-L1 nerve roots and can provide analgesia for lower abdominal procedures. In this study we aim to investigate the analgesic efficacy and safety of USG-guided bilateral TFP block in comparison with UGS-guided bilateral TAP block in patients undergoing cesarean section. |