跳至主要内容
临床试验/CTRI/2025/03/082175
CTRI/2025/03/082175尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年4月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
SGPGIMS
入组人数
74
试验地点
1
主要终点
Total fentanyl consumption in 48 hours by use of IV Patient Controlled

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 48 hours

Analgesia.

时间窗: 48 hours

次要结局

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

研究者

发起方
SGPGIMS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Rafat Shamim

Sanjay Gandhi Post graduate institute of medical science

研究点 (1)

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