| CTRI Number |
CTRI/2024/08/072070 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| 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
|
Effect of thoracolumbar muscle plane block on postoperative pain and inflammation in spine surgery patients. |
|
Scientific Title of Study
|
Comparison of the Post-operative pain and its association with Interleukins with or without Classical Thoracolumbar Inter-fascial Plane Block in Lumbar Spine Surgeries: A Prospective Double-blinded Randomized Controlled 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 |
Ruchi Verma |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, A block, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow, U.P. India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004221393 |
| Fax |
|
| Email |
ruchiv197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreya Chhabra |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, A block, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow, U.P. India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
7456022063 |
| Fax |
|
| Email |
shreyachhabra0504@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ruchi Verma |
| Designation |
Additional Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, A block, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow, U.P. India
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004221393 |
| Fax |
|
| Email |
ruchiv197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli road, Lucknow, India. PIN 226014 |
|
|
Primary Sponsor
|
| Name |
Ruchi Verma Department of Anaesthesiology |
| Address |
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Raebareli Road, Lucknow, India. PIN 226014 |
| 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 Ruchi Verma |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Neurosurgery operation theatre and Neurosurgery ICU and ward, G block, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Raebareli Road
Lucknow
UTTAR PRADESH |
8004221393
ruchiv197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 137th Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Single shot Classical thoracolumbar fascial plane block + standard pain management protocol |
Classical thoracolumbar fascial plane block using 20 ml of 0.375% Ropivacaine, + Inj. Paracetamol 1 gm IV 6 hourly, Inj. Tramadol 50 mg slow i.v. infusion on demand of the patient or when VAS score is 4 or more than 4. All the patients will be followed till 48 hours of surgery. |
| Comparator Agent |
Standard pain management protocol |
Paracetamol 1 gm IV 6 hourly, Inj. Tramadol 50 mg slow i.v. infusion on demand of the patient or when VAS score is 4 or more than 4. All the patients will be followed till 48 hours of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will give consent, ASA Physical status I or II, Scheduled for lumbar spine surgery |
|
| ExclusionCriteria |
| Details |
Patients with allergy to local anaesthetic, Coagulaton disorder, Infection at injection site, Chronic NSAID or opioid use, BMI more than 30 Kg/m2, Patients with neuromuscular disorder, Patients having chronic inflammatory disease, Patients with pre- existing autoimmune diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain assessment as per Visual analog scale (VAS) score. |
VAS score at 1, 6, 12, 24 and 48 hours in postoperative period in both the group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Variation in Serum levels of IL-1, IL-6, IL-4 and IL-10
2. Total Intraoperative opioid consumption,
3. Postoperative rescue analgesia requirement
4. Postoperative nausea and vomiting
5. Time to hospital discharge.
|
1. At baseline, 6 hours, 24 hours and 48 hours
2. At the end of surgery
3 & 4. 1 hour, 6 hours, 12 hours, 24 hours and 48 hours
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3 |
|
Date of First Enrollment (India)
|
14/08/2024 |
| 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
|
Postoperative pain following spine surgeries is a major obstacle to the early recovery of patients. Pain occurs because of release of proinflammatory cytokines such as IL-1, IL-6, TNFα and anti-inflammatory cytokines like IL-4, IL-10, TGF. The thoracolumbar interfascial plane (TLIP) block is a novel block that provides adequate analgesia after lumbar spine surgery. It provides analgesia in the area of major paraspinal nerves, which are innervated by the dorsal root of the thoracolumbar nerve and also modulates the level of proinflammatory and anti-inflammatory cytokines thereby relieving postoperative pain. There are very few studies comparing the effect on the levels of pro and anti-inflammatory cytokines after classical thoracolumbar interfascial plane (cTLIP) block and none of the studies had a comparison with the control group. Therefore, we designed this prospective, double blind, randomized controlled trial to study the effect of classical thoracolumbar interfascial plane block on IL-1, IL-6, IL-4 and IL-10 levels in lumbar spine surgeries. After approval from the Institute Ethical Committee (IEC), ASA grade I and II patients will be included. Written informed consent will be taken and patients will be randomized into two groups: • Group T: Patients receiving cTLIP block + standard pain management protocol, n=45 • Group C: Patients receiving standard pain management protocol, n=45 After appropriate randomization, patient will be taken in operation theatre and monitoring will be attached. Baseline blood sample will be collected and after induction of anaesthesia patients will be positioned prone. 20 ml, 0.375% ropivacaine at the level of L3 lumbar vertebrae between m.multifidus and m.longissimus will be given in group T over the standard pain management protocol and only the standard pain management protocol will be followed in group C. Remaining blood samples will be collected at 6, 24 and 48 hours. Visual Analogue Score will be assessed at 1 hour, 6 hours, 12 hours, 24 hours and 48 hours post extubation. Post-operative nausea vomiting will also be assessed at the same time points. The time of first rescue analgesia and total rescue analgesic requirement in 48 hours will be noted and time to hospital discharge will also be calculated. |