| CTRI Number |
CTRI/2025/07/090897 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| 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
|
To compare ultrasound guided thoracolumbar interfascial plane block and
erector spinae block for postoperative pain management in spine surgery |
|
Scientific Title of Study
|
" A STUDY TO COMPARE ULTRASOUND GUIDED THORACOLUMBAR INTERFASCIAL PLANE BLOCK (TLIP) AND ERECTOR SPINAE BLOCK (ESP) IN PATIENTS UNDERGOING SPINE SURGERY "- A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY.
|
| 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 Renuka GN |
| Designation |
Postgraduate ,Department Of Anaesthesiology |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD |
| Address |
DEPARTEMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL,MANJUSHREE NAGAR ,SATTUR, DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
6361935351 |
| Fax |
|
| Email |
renukagn511@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHILPA AGNIHOTRI |
| Designation |
ASSOCIATE PROFESSOR, DEPARTEMENT OF ANAESTHESIOLOGY |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD |
| Address |
DEPARTEMENT OF ANASTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, MANJUSHREE NAGAR ,SATTUR ,DHARWAD
Dharwad
KARNATAKA
580009
India |
| Phone |
9986066030 |
| Fax |
|
| Email |
docshilpa04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR. SHILPA AGNIHOTRI |
| Designation |
ASSOCIATE PROFESSOR DEPARTEMENT OF ANASTHESIOLOGY |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
DEPARTEMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL,MANJUSHREE NAGAR,SATTUR, DHARWAD.
Dharwad
KARNATAKA
580009
India |
| Phone |
9986066030 |
| Fax |
|
| Email |
docshilpa04@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
SDM COLLEGE OF MEDICAL SCIENCE |
| Address |
SDM COLLEGE OF ME
DICAL SCIENCES AND HOSPITAL,MANJUSHREE NAGAR, SATTUR, DHARWAD – 580009
|
| Type of Sponsor |
Private 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 |
| Renuka GN |
SDM COLLEGE OF MEDICAL SCIENCE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY
2nd FLOOR SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR, SATTUR, DHARWAD
Dharwad
KARNATAKA |
636193551
renukagn511@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM COLLEGE OF MEDICAL SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, (2) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems, (3) ICD-10 Condition: R52||Pain, unspecified, (4) ICD-10 Condition: R52||Pain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae plane block |
Ultrasound-guided ESP block performed bilaterally using 0.25% Bupivacaine, 20 ml on each side (total 40 ml). Injection given between the erector spinae muscle and the transverse process at the L3 level,performed under general anaesthesia |
| Intervention |
Thoracolumbar interfascial plane block |
Ultrasound guided Thoracolumbar Interfascial Plane Block performed bilaterally using 0.25%bupivacaine, 20ml on each side (total 40ml). Injection given between the multifidus and longissimus muscles at lumbar vertebral level, performed under general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. PATIENTS age between 18-70 years.
2. Patients belonging to ASA grade 1, 2 and 3 patients.
3. Patients undergoing thoracolumbar spine surgery
|
|
| ExclusionCriteria |
| Details |
1. Patients age less than 18years and more tahn70 years
2. Patel belonging to ASA grade 4
|
|
|
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 |
At the end of study we hope to ascertain the best
post operative analgesia among the two by comparing duration of analgesia.
|
0 to 24 hours postoperatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain score and total number of rescue analgesics |
Vas score 1,2,6,12 and 24 hrs and rescue analgesics time points 0 to 24hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/07/2025 |
| 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)
|
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
|
Title:
A study to compare ultrasound-guided thoracolumbar interfascial plane block (TLIPB) and erector spinae plane block (ESPB) in patients undergoing spine surgery – A prospective randomized controlled double-blind study.
Summary:
This is a prospective, randomized, controlled, double-blind study designed to compare the analgesic efficacy of ultrasound-guided thoracolumbar interfascial plane block (TLIPB) and erector spinae plane block (ESPB) in patients undergoing elective thoracolumbar spine surgery. The primary objective is to evaluate and compare the duration of postoperative analgesia provided by both blocks. Secondary objectives include assessing postoperative pain scores and total rescue analgesic consumption within the first 24 hours.
A total of 60 adult patients (ASA I–III), aged 18–70 years, will be randomized into two equal groups: one receiving TLIPB and the other ESPB using 0.25% bupivacaine (20 ml per side). Pain will be assessed using the Visual Analog Scale (VAS) at predefined intervals. The time to first rescue analgesic and total number of rescue doses will be recorded. Statistical analysis will include t-tests, Mann-Whitney U, and chi-square tests. This study aims to identify the more effective block technique for optimizing postoperative pain control in spine surgeries. |