| CTRI Number |
CTRI/2024/12/077861 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare Erector spinae plane block and posterior quadratus lumborum block for post-op analgesia for lower abdominal surgeries. |
|
Scientific Title of Study
|
A prospective randomised comparison of ultrasound guided erector spinae plane block versus posterior quadratus lumborum block for postoperative analgesia in patients undergoing lower abdominal surgeries |
| 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 Sweta |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jheelam Singh |
| Designation |
Senior Resident |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anaesthesiology LLRM Medical College Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
6398478017 |
| Fax |
|
| Email |
jheelamsingh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology LLRM Medical College Meerut Uttar Pradesh India 250004 |
|
|
Primary Sponsor
|
| Name |
LLRM Medical College Department of Anaesthesiology |
| Address |
Room No.2, Ground floor, Near IT Parking, LLRM Medical College Meerut Uttar Pradesh India 250004 |
| 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 Sweta |
LLRM Medical College |
Department of anaesthesiology LLRM Medical College
Meerut
UTTAR PRADESH |
8750933442
swetaanae@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Principal, LLRM Medical College, Meerut, Institutional Ethical Committee |
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 |
| Comparator Agent |
Erector spinae plane block |
Inj. ROPIVACAINE with Inj Dexmedetomidine is injected into the plane between the erector spinae muscle and transverse process of thoracic vertebra after completion of surgery |
| Comparator Agent |
Posterior quadratus lumborum block |
Inj.ROPIVACAINE and Inj.Dexmeditomidine distributes along the thoracolumbar fascia and the endothoracic fascia into the paravertebral space and cranially to T10 segment after completion of surgery |
| Intervention |
Regional Blocks for post-op analgesia |
Erector spinae block and posterior quadratus lumborum block will be given with Inj. ROPIVACAINE AND DEXMEDITOMIDINE as adjuvant |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I and II Patients.
2. Weight: 50-70kg.
3. Pt undergoing elective lower abdominal surgeries. |
|
| ExclusionCriteria |
| Details |
1. Pt refusal.
2. Infection at injection site.
3. Coagulopathy
4. Any systemic illness( DM, HTN).
5. Obesity
6. Known allergy or hypersensitivity to LA drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post-op analgesia |
30min,1hr,2hrs,12hrs,24hrs after completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total rescue analgesia consumption in 24 hrs |
For success of block |
| Duration of sensory block |
Till requirement of rescue analgesia |
| Any complication(post-op nausea and vomiting, bradycardia) |
Postoperatively after completion of surgery |
| Post-op quality of recovery score |
After extubation |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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
|
It is a prospective randomised study comparing efficacy of Erector spinae plane block and posterior quadratus lumborum block for post-op analgesia in adult patients undergoing lower abdominal surgeries. |