| CTRI Number |
CTRI/2025/03/082175 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effectiveness of Two Pain Relief Methods After Lumbar Spine Surgery: Ultrasound-guided mTLIP Block vs MTP Block
|
|
Scientific Title of Study
|
Comparative Evaluation of Post-operative analgesic efficacy of Ultrasound-guided Modified Thoraco lumbar
interfascial plane (mTLIP) block with Mid -transverse process to pleura (MTP) block in patients undergoing lumbar
spine surgeries : A Prospective Randomised Observer Blinded 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 |
Dr Rafat Shamim |
| Designation |
Associate professor |
| Affiliation |
Sanjay Gandhi Post graduate institute of medical science |
| Address |
Dr Rafat Shamim
Associate professor
Department of Anesthesiology
SGPGIMS LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
917839127067 |
| Fax |
|
| Email |
shamim.shamim15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi K |
| Designation |
Junior resident |
| Affiliation |
Sanjay Gandhi Post graduate institute of medical science |
| Address |
M1 903,
Sanjay Gandhi Post graduate institute of medical science and research centre
39/45 Veerapandian street Perambur Chennai Tamilnadu-600039
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
9952988408 |
| Fax |
|
| Email |
meenalatha96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rafat Shamim |
| Designation |
Associate professor |
| Affiliation |
Sanjay Gandhi Post graduate institute of medical science |
| Address |
Dr Rafat Shamim
Associate professor
Department of Anesthesiology
SGPGIMS LUCKNOW
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
917839127067 |
| Fax |
|
| Email |
shamim.shamim15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGPGIMS |
| Address |
Sanjay Gandhi Post graduate institute of medical science |
| 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 Rafat Shamim |
Sanjay gandhi post graduate institute of medical science |
Apex trauma centre,
OT complex,
First floor,
Department of Anaesthesiology
Sanjay Gandhi Post graduate institute of medical science
Lucknow
UTTAR PRADESH |
7839127067
shamim.shamim15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee SGPGI |
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 |
Mid transverse process to pleural block |
Mid transverse process to pleural block is given to patients undergoing lumbar spine surgery surgery and their post operative fentanyl consumption in 48 hours is calculated. |
| Comparator Agent |
Modified thoracolumbur interfacial plane block |
Modified thoracolumbur interfacial plane intercostal plane block given to patients undergoing lumbar spine surgery and post operative fentanyl consumption in 48 hours is calculated. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who had given written informed consent
2. Patients belonging to ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
1.Patients who has refused to undergo this study.
2.ASA grade III and IV
3.Pregnant females
4.Patient who are allergic to local anesthetics
5.Patients with abnormal coagulation profile
6.Patients who have active skin infection at injection site
7.Patients with neuromuscular disorder
8. Patients with pre-existing autoimmune diseases
9.Patient with cognitive impairment, delirium and dementia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total fentanyl consumption in 48 hours by use of IV Patient Controlled
Analgesia. |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Static & Dynamic Pain assessment by Mean NRS (Numeric Rating Scale)
2.Patient satisfactory score
3.Post operative nausea & vomiting
4.Block Procedure Time
5. Total rescue analgesia used in 48 hours
|
48h ours |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
08/04/2025 |
| 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="0"
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
|
Approximately 50% of lumbar spine surgery patients experience severe post-operative pain. Pain can lead to various complications such as prolonged immobilization and the need for prolonged opioid use.Various modalities can be used for post-operative pain management like opioids, epidural and various blocks.None of the studies compared mTLIP block with MTP block in lumbar spine surgeries to the best of our knowledge.Therefore we wish to compare the post op analgesic efficacy of mTLIP block and MTP block. Our aim comparison of the post operative analgesic efficacy of ultrasound guided Modified Thoraco lumbar interfascial plane (mTLIP) block with Mid -transverse process to pleura (MTP) block who are undergoing lumbar spinal surgery under general anesthesia (GA). Our primary objective total fentanyl consumption in 48 hours by use of IV Patient Controlled Analgesia. Secondary Objectives are Static and Dynamic Pain assessment by Mean NRS (Numeric Rating Scale), Patient satisfactory score, Post operative nausea and vomiting, Block Procedure Time, Total rescue analgesia used in 48 hours In our study patients will be randomly divided into two groupsmTLIP and MTP group Standard ASA monitors will be attached and GA will be given.Ventilator settings will be adjusted to maintain ETCO2 33-36mmHg.Subject will be positioned prone Group mTLIP - a curvilinear low frequency probe is placed in the transverse orientation at the midline at the level of the iliac crest and is moved laterally until the longissimus and iliocostalis muscles and in the plane between these two muscle 20mL of 0.2% ropivacaine will be injected Group MTPlinear US probe to be placed in the parasagittal position 3 cm away from midline, needle will be advanced to the mid-point between the transverse process and the pleura and 20mL of 0.2% ropivacaine will be injected.Block will be placed bilaterally.Total amount of fentanyl consumption will be observed. |