| CTRI Number |
CTRI/2025/08/093575 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two types of nerve blocks (quadratus lumborum vs transversus abdominis plane) to control pain after cesarean section |
|
Scientific Title of Study
|
A Comparative Study Of the Analgesics Efficacy of Ultrasound-Guided Quadratus Lumborum Block(QL) VS Transversus Abdominis Plane (TAP)Block For Patients Undergoing Elective Caesarean Section In a Tertiary Care Hospital A Prospective Randomised Double Blinded Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratheeksha Ballal |
| Designation |
Postgraduate student |
| Affiliation |
Shri Sathya sai medical college and research institute |
| Address |
Department of Anaesthesiology
2nd floor ,hospital block
Shri Sathya sai medical college and research institute
Ammapettai Kancheepuram Tamil nadu India
Department of Anaesthesiology
2nd floor , Hospital block Shri Sathya sai medical college and research institute
Ammapettai Kancheepuram Tamil nadu India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9448965734 |
| Fax |
|
| Email |
ballalpratheekshaballal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Dr Dilip Kumar. G |
| Designation |
HOD and Proffesor |
| Affiliation |
Shri Sathya sai medical college and research institute |
| Address |
Department of Anaesthesiology
2nd floor , Hospital block
Shri Sathya sai medical college and research institute
Ammapettai Kancheepuram Tamil nadu India
Department of anaesthesiology
2nd floor , Hospital block
Shri Sathya sai medical college and research institute
Ammapettai Kancheepuram Tamil nadu India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9094940243 |
| Fax |
|
| Email |
dilipko@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratheeksha Ballal |
| Designation |
Postgraduate student |
| Affiliation |
Shri Sathya sai medical college and research institute |
| Address |
Department of Anaesthesiology
2nd floor , Hospital block
Shri Sathya sai medical college and research institute
Ammapettai Kancheepuram Tamil nadu India
Department of Anaesthesiology
2nd floor , Hospital block
Shri Sathya sai medical college and research institute
Ammapettai Kancheepuram Tamil nadu India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9448965734 |
| Fax |
|
| Email |
ballalpratheekshaballal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Pratheeksha Ballal |
| Address |
SSSMCRI womens hostel
Shri Sathya Sai Medical College And Research Institute
Ammapettai Kancheepuram
Tamil Nadu India |
| Type of Sponsor |
Other [Self] |
|
|
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 Pratheeksha Ballal |
Shri Sathya Sai Medical college and Research institute |
Department of Anaesthesiology
2nd floor , hospital block ,Shri Sathya Sai Medical college and Research Institute
Kancheepuram
TAMIL NADU |
09448965734
ballalpratheekshaballal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus Lumborum Block |
20ml of 0.25percentage BUPIVACAINE injected using ultrasound guidance |
| Comparator Agent |
Transversus Abdominis Plane block |
20ml of 0.25percentage of BUPIVACAINE injected using ultrasound guidance and compared for analgesics efficacy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients falling under ASA physical status I and II
2.Patients under the Age 18 to 40 years
3.Patient with BMI of18 to 35
|
|
| ExclusionCriteria |
| Details |
1.Patients Allergic to local anaesthetics
2.Patients with Seizure disorders
3.Patients with Coagulopathy or anticoagulant therapy
4.Patient with Infection at injection site
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score using Visual Analogue Scale (VAS) at rest and movement over 24 hours |
Pain score (VAS at rest and on movement) at 1, 4, 8, 12, and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
This study is a prospective randomized double blinded controlled trial being conducted at Sri Sathya Sai Medical College and Research Institute. It aims to compare the analgesic efficacy of ultrasound guided quadratus lumborum block and transversus abdominis plane block in women aged 18 to 40 years with ASA physical status I or II undergoing elective caesarean section under spinal anaesthesia. A total of 70 participants will be randomized into two groups of 35 each. Group QL will receive 20 ml of 0.25 percent bupivacaine bilaterally in the quadratus lumborum block and Group TAP will receive 20 ml of 0.25 percent bupivacaine bilaterally in the transversus abdominis plane block. The primary objective is to compare the duration of effective postoperative analgesia between the two groups using visual analogue scale scores, while secondary objectives include assessing the time to first rescue analgesia, total analgesic consumption, and adverse events. Institutional ethics committee approval has been obtained and written informed consent will be taken from all participants. |