| CTRI Number |
CTRI/2025/06/088995 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2025 |
| 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
|
For post operative pain management in lumber spine surgery, comparison between USG guided erector spinae muscle plane block and local anaesthetic infiltration at incision site. |
|
Scientific Title of Study
|
To determine the effect of USG guided erector spinae plane block on postoperative analgesia in patients undergoing lumbar spine surgery: A Randomized Control Trial |
| 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 Basant Kumar Dindor |
| Designation |
Associate professor |
| Affiliation |
RNT medical college,udaipur,rajasthan |
| Address |
Department of Anaesthesiology, RNT medical college Udaipur,
Rajasthan
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9602237852 |
| Fax |
|
| Email |
basant_17@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basant Kumar Dindor |
| Designation |
Associate professor |
| Affiliation |
RNT medical college,udaipur,rajasthan |
| Address |
Department of Anaesthesiology, RNT medical college Udaipur,
Rajasthan
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9602237852 |
| Fax |
|
| Email |
basant_17@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilkhush Meena |
| Designation |
Post Graduate Resident |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesiology,
RNT medical college Udaipur,
Rajasthan
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
8058553194 |
| Fax |
|
| Email |
dilkhushdamor1994@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Complex, super speciality block, RNT Medical College Udaipur, Rajasthan , INDIA ,PINCODE- 313004 |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of Anaesthesiology,
RNT medical college Udaipur,
Rajasthan
Udaipur
RAJASTHAN
313001
India |
| 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 DILKHUSH MEENA |
Maharana Bhupal Government Hospital |
OT Complex, Super Speciality Block, RNT Medical college Udaipur, Rajasthan
Udaipur
RAJASTHAN |
8058553194
dilkhushdamor1994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS,UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local Infiltraion of Local Anesthetic agent |
20ml of 0.5% ropivaciane at the incision site |
| Intervention |
USG guided Erector Spinae Plane block |
20ml of 0.5% ropivacaine at T10 level |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anesthesiologists physical status I-II.
2.Scheduled for elective unilateral Lumbar spine surgery under GA. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Patient with
I. Coagulopathies or on anticoagulant medication,
II. Complex surgery involving more the two lumbar vertebral level
III. With absolute contraindications to ESPB.
IV. Low cognitive function that would make VAS score
difficult to assess.
3. History of allergic reaction to study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare postoperative duration of analgesia |
In 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total analgesic consumption in 24 hours.
2. Pain relief between the two groups using visual analogue scale (VAS) score.
3. Any hemodynamic changes.
4. Adverse effects / complications if any. |
In 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
30/06/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
The aim of the study will be to compare the efficacy of ultrasonography (USG) guided ESPB with local anesthetic infiltration at the incision site using Ropivacaine (0.5%) in providing postoperative analgesia followingLumber Spine Surgery. |