| CTRI Number |
CTRI/2021/02/031289 [Registered on: 15/02/2021] Trial Registered Prospectively |
| Last Modified On: |
12/02/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Three regional anaesthesia techniques for post cesarean section analgesia |
|
Scientific Title of Study
|
Comparison of quadratus lumborum block, erector spinae plane block and transversus abdominis plane block for post cesarean section analgesia: A prospective randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aman Malawat |
| Designation |
Senior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
c/o Dr Durga Jethava Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7737200883 |
| Fax |
|
| Email |
dr.a.malawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aman Malawat |
| Designation |
Senior Resident |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
c/o Dr Durga Jethava Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur
RAJASTHAN
302022
India |
| Phone |
7737200883 |
| Fax |
|
| Email |
dr.a.malawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Durga Jethava |
| Designation |
PHOD Department Of Anaesthesiology |
| Affiliation |
Mahatma Gandhi Medical College and Hospital, Jaipur |
| Address |
Department Of Anaesthesiology RIICO Institutional Area, Sitapura, Jaipur 302022 Jaipur RAJASTHAN
Jaipur
RAJASTHAN
302022
India |
| Phone |
9414452382 |
| Fax |
|
| Email |
djethava@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr Aman Malawat |
| Address |
c/o Dr Durga Jethava Department Of Anaesthesiology Mahatma Gandhi Medical College and Hospital RIICO Institutional Area Sitapura Tonk Road Jaipur 302033 Rajasthan |
| 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 Aman Malawat |
Mahatma Gandhi Medical College and Hospital |
Department Of Anaesthesiology RIICO Institutional Area, Sitapura, Jaipur 302022 Jaipur 302022 RAJASTHAN
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7737200883
dr.a.malawat@gmail.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: O749||Complication of anesthesia duringlabor and delivery, unspecified, (2) ICD-10 Condition: O758||Other specified complications of labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
bilateral ultrasonographic Erector spinae plane block using ropivacaine.
Route of administration: Musculofascial plane
Duration of therapy: single time. |
| Comparator Agent |
Quadratus lumborum block |
bilateral ultrasonographic quadratus lumborum block using ropivacaine.
Route of administration: Musculofascial plane
Duration of therapy: single time. |
| Intervention |
Transversus abdominis plane block |
bilateral ultrasonographic transversus abdominis plane block using ropivacaine.
Route of administration: Musculofascial plane
Duration of therapy: single time. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient with ASA Class II, III
2. Normal singleton pregnancy with a gestation of at least 37 weeks
3. Patient’s written and informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient with ASA Class IV & V
2. Patient refusal
3. Local infection at the site of injection
4. Allergy to study medications
5. Anatomic abnormalities
6. Systemic anticoagulation or coagulopathy
7. Inability to comprehend or participate in pain scoring system |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time of first rescue analgesic needed. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total cumulative dose of analgesic needed in first 48 hours after surgery. |
48 hours |
| To compare severity of postoperative pain via visual analogue pain scale at rest (VASR) and with movement (dynamic) |
48 hours |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
21/02/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to compare the analgesic efficacy of quadratus lumborum block, erector spinae plane block and TAP block in patients who had cesarean section under spinal anesthesia |