| CTRI Number |
CTRI/2026/03/106127 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| 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
|
Pain relief after Thoracolumbar spine surgery in adults : A Randomised study comparing Thoracolumbar Interfascial Plane (TLIP) block and Erector Spinae Plane block (ESPB) . |
|
Scientific Title of Study
|
The Analgesic Efficacy of Thoracolumbar Interfascial Plane block (TLIP) versus Erector Spinae Plane block (ESPB) for Thoracolumbarspine surgeries – A Randomised controlled 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 |
Vasudev shenoy |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
7022278966 |
| Fax |
|
| Email |
kvasudevshenoy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Waindeskar |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Waindeskar |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences, Bhopal |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
9575604490 |
| Fax |
|
| Email |
vaishali.anesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhopal, Saket Nagar , Bhopal , Madhya pradesh, India - 462020 (non funded) |
|
|
Primary Sponsor
|
| Name |
Dr Vaishali Waindeskar |
| Address |
Department of Anesthesiology, AIIMS Bhopal, Saket Nagar, 462020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vasudev shenoy |
AIl India Institute of medical sciences , Bhopal |
Modular Operation
Theatre, Department Of
Anesthesiology, AIIMS
Bhopal , Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH |
7022278966
kvasudevshenoy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhopal Institutional Human Ethics Comittee- student research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M539||Dorsopathy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ultra sound guided Erector Spinae Plane block for adult patients undergoing thoracolumbar spine surgeries under GA |
All patients will receive standard general anaesthesia followed by bilateral Erector spinae block using 20 ml of 0.25% levobupivacaine with 1 ug/kg of dexmedetomidine. (20ml each side )
The block will given prior to incision and patient handover will be given 20 minutes after the block is given . |
| Intervention |
Ultra sound guided Thoracolumbar Interfascial Plane block in adult patients undergoing thoracolumbar spine surgeries under GA |
All patients will receive standard general anaesthesia followed by bilateral Thoracolumbar interfascial plane block using 20 ml of 0.25% levobupivacaine with 1ug/kg of dexmedetomidine . (20ml each side )
The block will given prior to incision and patient handover will be given 20 minutes after the block is given . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
18-65 years of age of any sex, ASA(American Society of Anaesthesiologists classification of Physical Status) I-II, scheduled for less than four level lumbar spine surgeries, in which the plan of anaesthesia is GA plus Regional block. Type of surgeries could include but are not restricted to:-
1. Single level laminectomy/laminotomy
2. Lumbar decompression surgeries
3. Posterior lumbar interbody fusion
4. Prolapsed intervertebral disc
5. Single level Microdiscectomy
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal to the block procedure
Contraindication to regional technique e.g., allergy to local anaesthetic drugs, block site, infection, coagulation disorders.
Body mass index>35 kg/m2
Pregnancy
Physical or mental disorders that would interfere with the evaluation of pain
Patients with skin lesions due to any disease
Patient on anti–epileptic drugs/ enzyme inducers as it would affect the metabolism of drugs
Local inflammation
|
|
|
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 |
| Duration of analgesia – defined by the time for first rescue analgesia after extubation |
2,6,12,24, 48 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual analogue score (VAS) at 2,6,12 and 24 , 48 hours at rest (supine position)and at activity defined as coughing
2. Total Intraoperative consumption of Fentanyl in mcg
3. Total postoperative Tramadol consumption till 48 hrs.
4. Patient satisfaction score (Likert score ) evaluated at 48 hrs
|
2,6,12,24, 48 hours after surgery |
|
|
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)
|
15/04/2026 |
| 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 Yet Recruiting |
| 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
|
Surgical
management is commonly required for degenerative and traumatic disorders of the
thoracolumbar spine, with postoperative pain presenting as a frequent and
significant challenge. The erector spinae plane (ESP) block, involves injection
of local anesthetic beneath the erector spinae muscle while the thoracolumbar interfascial plane (TLIP)
block targets the plane between the longissimus and multifidus muscles and
primarily attenuates pain via blockade of the dorsal rami . Participants will be divided into 2 groups - Group EP : All
patients will receive standard general anaesthesia followed by bilateral
Erector spinae block using 20 ml of 0.25% levobupivacaine with 1 ug/kg of
dexmedetomidine. (20ml each side )Group TP : All patients will receive standard
general anaesthesia followed by bilateral Thoracolumbar interfascial plane block
using 20 ml of 0.25% levobupivacaine with 1ug/kg of dexmedetomidine . (20ml
each side ) .primary and secondary outcomes will be measured at 2,6,12,24,4
hours . |