| CTRI Number |
CTRI/2024/11/077221 [Registered on: 22/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post cesarean pain management efficacy of regional blocks Quadratus lumborum block and Transversus abdominis plane block using Ropivacaine 0.25percent under Ultrasound guidance. |
|
Scientific Title of Study
|
A Comparative Study of Analgesic profile in Quadratus Lumborum Block and Transversus Abdominis Plane Block(TAP Block) using Ultrasound guidance with Ropivacaine 0.25percent in Post LSCS patients 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. Somnath Mardi |
| Designation |
Junior Resident |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Bariatu, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9031827946 |
| Fax |
|
| Email |
gleamsom10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ekramul Haque |
| Designation |
Associate Professor |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9431101186 |
| Fax |
|
| Email |
ekramrims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manisha Bhagat |
| Designation |
Assistant Professor |
| Affiliation |
Rajendra Institute of Medical Sciences, Ranchi |
| Address |
Department of Anesthesiology, Rajendra Institute of Medical Sciences, Ranchi
Ranchi
JHARKHAND
834009
India |
| Phone |
9386269477 |
| Fax |
|
| Email |
bhagatmanisha7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajendra Institute of Medical Science, Bariatu, Ranchi,Jharkhand, Pin code -834009 |
|
|
Primary Sponsor
|
| Name |
Rajendra Institute of Medical Sciences |
| Address |
Rajendra Institute of Medical Science, Bariatu, Ranchi, Pin-834009 |
| Type of Sponsor |
Government 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 Somnath Mardi |
Rajendra Institute of Medical Sciences, Ranchi |
Department of Anesthesiology, Bariatu, Ranchi, Jharkhand, Pin 834009
Ranchi
JHARKHAND |
9031827946
gleamsom10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rajendra Institute of Medical Sciences, Ranchi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus lumborum plane block |
After closure of skin in post Lscs patients under subarachnoid block 20ml of 0.25% Ropivacaine is given on each side using ultrasound guidance. |
| Comparator Agent |
Transversus abdominis plane block |
After closure of skin in post lscs patients under subarachnoid block 20ml of 0.25% Ropivacaine is given on each side using ultrasound guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
patients with caesarean section under spinal anesthesia
ASA GRADE 1&2
BMI Less than 30kg/m2
|
|
| ExclusionCriteria |
| Details |
Known case of central neuropathy, diabetes mellitus with peripheral neuropathy, psychiatric illness, hepatic and renal impairment, coagulation disorder.
allergic to study medicine.
BMI more than 30kg/m2
ASA GRADE 3 or more |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the analgesic efficacy of Quadratus lumborum plane block and Transversus abdominis plane block in post Lscs patients. |
Visual analogue score at
2hours
4hours
6hours
8hours
12hours
24hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study total doses of rescue analgesia in these patients.
To compare the incidence of post operative nausea vomiting |
Rescue analgesia
Inj Paracetamol or Inj tramadol at 2hours, 4hours, 6hours, 8hours, 12hours, 24hours.
Post operative nausea vomiting at 2hours, 4hours, 6hours, 8hours, 12hours,24hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="0"
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
|
Post caesarean pain ranges from moderate to severe in first 24 hours. Many studies suggest that pain affects the healing process, early mobility and is a risk for post partum depression. Multiple modalities have been used in past for effective analgesia with new analgesics and delivery techniques. Regional nerve blocks using ultrasound guidance has evolved in recent years for post operative pain in abdominal surgeries reducing the consumption of opioids. In this study two different blocks Transversus Abdominis Plane Block and Quadratus Lumborum Block have been compared for effective management of post caesarean pain. After identification of site using ultrasound guidance local anesthetic Ropivacaine 0.25% is infiltrated bilaterally for each block. Visual analogue scale is utilized to study the analgesic efficacy in first 24 hours. |