跳至主要内容
临床试验/CTRI/2025/09/094255
CTRI/2025/09/094255尚未招募不适用

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

Bharati hospital and research centre1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
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

研究概览

简要总结

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.

研究设计

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

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Adults with ASA I-III Patients undergoing elective one or two level posterior lumbar interbody fusion surgery.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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

次要结局

  • 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)

研究者

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

Dr Anubhav Mohanty

Bharati vidyapeeth deemed to be university

研究点 (1)

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