跳至主要内容
临床试验/CTRI/2025/02/080351
CTRI/2025/02/080351尚未招募不适用

Comparative Efficacy of Ultrasound-Guided Sacral Erector Spinae Plane Block and Wound Infiltration in Transforaminal Lumbar Interbody Fusion: A Randomized Controlled Trial

All India Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
试验地点
1
主要终点
. To compare the postoperative opioid consumption between sacral ESP block and Wound Infiltration in patients undergoing TLIF surgeries under general anaesthesia.

研究概览

简要总结

Transforaminal Lumbar interbody Fusion surgery (TLIF) is a surgery indicated in degenerative disc disease, spinal stenosis, spondylolisthesis, low back pain with sciatica symptoms and facet joint pain.Adequate analegia post surgery becomes important in these patients for early rehabilitation. Incision site infiltration with local anesthetics is commonly used in these patients. A novel technique of injection of local anaesthetic at sacrum S2 level has been found to be effective in anorectal surgery. Recently in a dye study lower lumbar spread of the dye has been found. With this knowledge we have planned a RCT comparing Sacral ESP and local wound infiltration in patient undergoing TLIF Surgery from any level from L1 to L5 for postoperative pain.

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 70.00 Year(s)(—)
性别
All

入选标准

  • • Either Sex • Age 18-70 years • Patients scheduled for Trans-foraminal Lumbar Interbody Fusion (TLIF) surgery.

排除标准

  • • Patient with coagulopathy • Patient allergic to local anaesthetic • Chronic opioid dependence or use of painkillers for more than 3 months • Inability to communicate due to severe dementia, language barrier, or end-stage disease • Comorbidity of the central and/or peripheral nervous system.

结局指标

主要结局

. To compare the postoperative opioid consumption between sacral ESP block and Wound Infiltration in patients undergoing TLIF surgeries under general anaesthesia.

时间窗: 30 min., 1 hr,2,4,8,12,24 hr postopeartively

次要结局

  • . To compare total intraoperative fentanyl requirement between the two groups.(2. To compare the time to first rescue analgesia requirement in the post-operative period between the two groups)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Sachin Kumar

All India Institute Of Medical Sciences,New Delhi

研究点 (1)

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