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Clinical Trials/CTRI/2025/03/082175
CTRI/2025/03/082175
Not yet recruiting
Not Applicable

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

SGPGIMS1 site in 1 country74 target enrollmentStarted: April 8, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
SGPGIMS
Enrollment
74
Locations
1
Primary Endpoint
Total fentanyl consumption in 48 hours by use of IV Patient Controlled

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patient who had given written informed consent
  • Patients belonging to ASA grade I and II.

Exclusion Criteria

  • 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
  • Patients with pre-existing autoimmune diseases 9.Patient with cognitive impairment, delirium and dementia.

Outcomes

Primary Outcomes

Total fentanyl consumption in 48 hours by use of IV Patient Controlled

Time Frame: 48 hours

Analgesia.

Time Frame: 48 hours

Secondary Outcomes

  • 1.Static & Dynamic Pain assessment by Mean NRS (Numeric Rating Scale)(2.Patient satisfactory score)

Investigators

Sponsor
SGPGIMS
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Rafat Shamim

Sanjay Gandhi Post graduate institute of medical science

Study Sites (1)

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