| CTRI Number |
CTRI/2020/08/027229 [Registered on: 19/08/2020] Trial Registered Prospectively |
| Last Modified On: |
17/08/2020 |
| 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
|
Comparison of postoperative analgesic effectiveness of Transverses Abdominis Plane (TAP) Vs Quadratus Lumborum (QL) block in patients undergoing Lower segment caesarean section |
|
Scientific Title of Study
|
Comparison of postoperative analgesic effectiveness of Transverses Abdominis Plane (TAP) Vs Quadratus Lumborum (QL) block in patients undergoing Lower segment caesarean section: a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kaminder bir Kaur |
| Designation |
Clinical Tutor |
| Affiliation |
Armed Forces Medical College |
| Address |
104, Project Quarters, Prince of Wales Drive, Pune Camp
Pune
MAHARASHTRA
411040
India |
| Phone |
9401087860 |
| Fax |
|
| Email |
rimshikohli@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kaminder bir Kaur |
| Designation |
Clinical Tutor |
| Affiliation |
Armed Forces Medical College |
| Address |
104, Project Quarters, Prince of Wales Drive, Pune Camp
Pune
MAHARASHTRA
411040
India |
| Phone |
9401087860 |
| Fax |
|
| Email |
rimshikohli@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kaminder bir Kaur |
| Designation |
Clinical Tutor |
| Affiliation |
Armed Forces Medical College |
| Address |
104, Project Quarters, Prince of Wales Drive, Pune Camp
Pune
MAHARASHTRA
411040
India |
| Phone |
9401087860 |
| Fax |
|
| Email |
rimshikohli@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Departmental Fund, Department of Anaesthesiology & Critical Care, AFMC, Pune |
|
|
Primary Sponsor
|
| Name |
Departmental funds |
| Address |
Department of Anaesthesiology & Critical Care, Armed Forces Medical College |
| Type of Sponsor |
Research institution |
|
|
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 Kaminder bir Kaur |
AFMC Dept of Anaesthesiology |
Department of Anaesthesiology & Critical Care, AFMC, Solapur Road, Pune 410040
Pune
MAHARASHTRA |
9401087860
rimshikohli@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Quadratus lumborum block |
Intervention will be given to all patients undergoing LSCS under GA/SAB on odd days and control group will be considered on even numbered days
Intervention arm: Patients will receive USG guided bilateral QL block
Control Arm; Patients will receive USG guided bilateral TAP block |
| Comparator Agent |
Ultrasound guided Transversus Abdomens Plane BLOCK |
Intervention will be given to all patients undergoing LSCS under GA/SAB on odd days and control group will be considered on even numbered days
Intervention arm: Patients will receive USG guided bilateral QL block
Control Arm; Patients will receive USG guided bilateral TAP block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Intervention will be given to all patients undergoing LSCS under GA/SAB on odd days and control group will be considered on even numbered days
Intervention arm: Patients will receive USG guided bilateral QL block
Control Arm; Patients will receive USG guided bilateral TAP block |
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency LSCS
Contrindications for SAB
Allergic to Local Anaesthetics
Patients of chronic pain syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain control in both the groups will be compared and is the primary objective |
Numeric rating scale is used to measure pain at 30min, 2hr,4hr, 6hr,12hr and 24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Duration of post operative analgesia and rescue analgesia with tramadol
2. Number of patients requiring rescue analgesia |
Time noted for getting the rescue analgesia till 24hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
23/08/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Multimodal pain management is the standard of care in the surgical patients in the post operative period. LSCS is considered as one of the most common surgeries the practice of the obstetrics. Opioids and other NSAIDs as the analgesics of choice ,have many adverse effects. Hence, establishing different methods other than conventional methods for post op analgesia are the current trend in practice of preoperative care. TAP blocks thoracic sensory nerves T7 - T12 with conventional approach and controls postoperative incisional pain. QLB can control the somatic pain after major abdominal surgery which can be performed in patients undergoing LSCS. It is also considered as an easily approached peripheral nerve block. The studies have shown that it is more or equally effective as TAP block. The prolongation of the duration of analgesia is always an added benefit to the patients. |