| CTRI Number |
CTRI/2025/09/094863 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare two nerve blocks which will be performed under ultrasound guidance among patients undergoing spine surgery and its efficiency in reducing pain and its efficacy in reducing the requirement of other pain relieving medications are compared |
|
Scientific Title of Study
|
Comparison of Ultrasound guided modified thoracolumbar interfascial plane block versus erector spinae plane block for pain relief among patients undergoing spine surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Keerthana |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ) |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ),
JIPMER Campus Road,
Gorimedu,
Dhanvantari Nagar,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9080859542 |
| Fax |
|
| Email |
keerthanarj24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N Ramya |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ) |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ),
JIPMER Campus Road,
Gorimedu,
Dhanvantari Nagar,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786668202 |
| Fax |
|
| Email |
dr.ramyaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N Ramya |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ) |
| Address |
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ),
JIPMER Campus Road,
Gorimedu,
Dhanvantari Nagar,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9786668202 |
| Fax |
|
| Email |
dr.ramyaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ),
JIPMER Campus Road,
Gorimedu,
Dhanvantari Nagar,
Puducherry,
605006. |
|
|
Primary Sponsor
|
| Name |
R Keerthana |
| Address |
Junior Resident,
Department of Anaesthesiology and Critical Care,
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ),
JIPMER Campus Road,
Gorimedu,
Dhanvantari Nagar,
Puducherry,
605006. |
| 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 R Keerthana |
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ) |
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER ),
JIPMER Campus Road,
Gorimedu,
Dhanvantari Nagar,
Puducherry,
605006.
Pondicherry
PONDICHERRY |
9080859542
keerthanarj24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE ( HUMAN STUDIES) JIPMER |
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 |
Ultrasound guided Erector spinae plane block |
Ultrasound guided Erector spinae plane block will be performed on either side with 20ml of 0.25% Bupivacaine with 8mg Dexamethasone |
| Intervention |
Ultrasound guided modified thoracolumbar interfascial plane block |
Ultrasound guided modified thoracolumbar interfascial plane block will be performed on either side with 20ml of 0.25% Bupivacaine with 8mg Dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA physical status I and II scheduled for lumbar level laminectomy or lumbar level decompression with or without posterior instrumentation |
|
| ExclusionCriteria |
| Details |
1. Patients with BMI more than 30kg/m2
2. Patients with Coagulopathy
3. Patients with local site infections
4. Patients who are allergic to local anesthetic drugs
5. Patient with psychiatric problems
6. Patients with neurological and neuromuscular disorders |
|
|
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 compare postoperative level of pain using VAS score between ultrasound guided modified thoracolumbar interfascial plane block and ultrasound guided erector spinae plane block among patients undergoing spine surgery |
Pain will be measured at 0, 2, 4, 8, 16 and 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the total opioid consumption in intraoperative period between the two groups |
Intraoperative period |
| To compare the total opioid consumption in the postoperative period between the two groups |
Postoperative period ( first 24 hours ) |
| To compare the time to first rescue analgesia between the two groups |
Postoperative period ( first 24 hours ) |
| To compare the patient satisfaction score between the two groups |
Postoperative period ( at the end of 24 hours ) |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
03/10/2025 |
| 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="6"
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
|
This study is a randomized, double blinded, parallel group, single-centre trial comparing ultrasound guided modified Thoracolumbar interfascial plane block with ultrasound guided Erector spinae plane block for pain relief in patients undergoing spine surgery. The primary outcome is to compare the postoperative pain scores at six defined time points between two groups. The secondary outcomes will be to compare intraoperative and postoperative ( first 24 hours) total opioid consumption, time to first rescue analgesia and patient satisfaction scores. |