| CTRI Number |
CTRI/2025/09/094255 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two types of pain relief injections namely Thoracolumbar Interfascial plane block and Erector Spinae plane block after lower back surgery |
|
Scientific Title of Study
|
A randomised controlled study to compare the efficacy of post-operative analgesia with Thoracolumbar Interfascial plane block and bilateral Erector Spinae plane block following Posterior Lumbar Interbody fusion 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 |
Dr Anubhav Mohanty |
| Designation |
Junior Resident |
| Affiliation |
Bharati vidyapeeth deemed to be university |
| Address |
Department of Anaesthesia,Bharati vidyapeeth deemed to be university,dhankawadi,pune
Pune
MAHARASHTRA
411043
India |
| Phone |
8249626284 |
| Fax |
|
| Email |
anubhavmohanty1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalyani Patil |
| Designation |
Professor |
| Affiliation |
Bharati vidyapeeth deemed to be university |
| Address |
Department of Anaesthesia,Bharati vidyapeeth deemed to be university,dhankawadi,pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9673400066 |
| Fax |
|
| Email |
kalyanish19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani Patil |
| Designation |
Professor |
| Affiliation |
Bharati vidyapeeth deemed to be university |
| Address |
Department of Anaesthesia,Bharati vidyapeeth deemed to be university,dhankawadi,pune
MAHARASHTRA
411043
India |
| Phone |
9673400066 |
| Fax |
|
| Email |
kalyanish19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati hospital and research Centre, Bharati vidyapeeth deemed to be university campus,Dhankawadi,Pune,Maharashtra,India,411043 |
|
|
Primary Sponsor
|
| Name |
Bharati hospital and research centre |
| Address |
Bharati vidyapeeth deemed to be university,dhankawadi,pune,411043 |
| 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 Anubhav Mohanty |
Bharati hospital and research centre |
Department of Anaesthesia,3rd floor,Bharati hospital and research centre,Dhankawadi,Pune,Maharashtra,411043
Pune
MAHARASHTRA |
8249626284
anubhavmohanty1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Institutional Ethical Committe |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
Ultrasound guided bilateral Erector Spinae plane block (ESPB) block using 0.375% ropivacaine (20 ml per side) |
ESPB block will be performed under ultrasound guidance using 0.375% ropivacaine (20 ml per side) after surgical closure and before extubation. ESPB will be given at the lumbar transverse process beneath the erector spinae muscle. The procedure will be done in the prone position, with blinded postoperative assessment. Rescue analgesia with intravenous paracetamol (1 g) will be provided if NRS pain scores exceed 3, and consumption will be recorded. |
| Comparator Agent |
Ultrasound guided Thoracolumbar Interfascial Plane (TLIP) block using 0.375% ropivacaine (20 ml per side) |
TLIP block will be performed under ultrasound guidance using 0.375% ropivacaine (20 ml per side) after surgical closure and before extubation.TLIP will be administered between the multifidus and longissimus muscles. The procedure will be done in the prone position, with blinded postoperative assessment. Rescue analgesia with intravenous paracetamol (1 g) will be provided if NRS pain scores exceed 3, and consumption will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults with ASA I-III
Patients undergoing elective one or two level posterior lumbar interbody fusion surgery |
|
| ExclusionCriteria |
| Details |
Contraindication to regional block such as coagulopathy and infection at the block site
History of opioid abuse
History of allergy to any drugs like local anesthetics and non-steroidal anti-inflammatory drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of recovery of postoperative analgesia with thoracolumbar interfacial plane block and bilateral erector spinae plane block following posterior lumbar interbody fusion spine surgery using NRS score |
Efficacy of recovery of postoperative analgesia with thoracolumbar interfacial plane block and bilateral erector spinae plane block following posterior lumbar interbody fusion spine surgery using NRS score at 4,8,12 and 24hrs postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 24hr recovery profile in patient receiving thoracolumbar interfacial plane block and bilateral erector spinae plane block following posterior lumbar interbody fusion spine surgery using QoR-15 questionnaire |
Recovery profile in patient receiving thoracolumbar interfacial plane block and bilateral erector spinae plane block following posterior lumbar interbody fusion spine surgery using QoR-15 questionnaire at 24hrs postoperative |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0"
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 randomized controlled study aims to compare the efficacy of thoracolumbar interfascial plane (TLIP) block and bilateral erector spinae plane (ESPB) block for postoperative analgesia in patients undergoing posterior lumbar interbody fusion (PLIF) spine surgery. After obtaining approval from institutional ethical committee and informed consent from the
patients , a total no. of 66 adult patients (ASA I–III, aged 18–60 years) will be randomly allocated into two groups, receiving either ESPB or TLIP block under ultrasound guidance with 0.375% ropivacaine after surgical closure and before extubation. Allocation will be concealed, and postoperative assessments will be blinded. The primary outcome is postoperative pain relief measured using the Numerical Rating Scale (NRS) at 2, 8, and 24 hours, while secondary outcomes include quality of recovery assessed with the QoR-15 questionnaire, total rescue analgesic consumption, and time to first rescue dose. Intravenous paracetamol will be used as rescue analgesia when NRS exceeds 3. The study seeks to determine the more effective block technique for improving postoperative pain control and recovery in lumbar spine surgeries. |