跳至主要内容
临床试验/CTRI/2019/05/018870
CTRI/2019/05/018870已完成1 期

Clinical efficacy of ultrasound guided bilateral erector spinae plane block for single level lumbar fusion surgery. A prospective, randomized, double blinded, case control study

Hospital administration2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月5日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Requirement of opioid analgesia in the perioperative period

研究概览

简要总结

Patients undergoing spine surgeries will have severeperioperative pain which leads to morbidity and demands adequate analgesia. Multimodal analgesia involving NSAIDS, intravenousparacetamol and steroids remains the mainstay for treating the pain in thesepatients. In spite of the adequate usage of the above drugs most of the patientmight require opioids in the immediate postoperative period due to severity ofpain. Regional anaesthesia in these cases is administered by giving the localanaesthetic in the epidural space or giving opioids epidurally orintrathecally, though they are rarely practised.  Erector spinae plane (ESP)block described in 2016 as a novel regional anesthetic technique for acute andchronic thoracic pain by Forerro et al [1]. It has also been usedfor postoperative analgesia for breast surgery [2] and abdominalsurgery [3]. With the advances in usage of ultrasound for regionalanaesthesia, the performance of plane blocks have become much easier and morereliable. The erector spinae plane block is a myofascial plane block where thelocal anaesthetics are deposited in the plane between the erector spinae muscleand the transverse process of the vertebrae. The local anaesthetic therebyblocks the dorsal rami of the spinal nerves mainly and also ventral rami. Weare studying the efficacy of ultrasound guided ESP block for perioperative analgesia onpatients undergoing single level lumbar spine fusion surgery with control group.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Patients requiring single level fusion surgery at lumbar spine (L1 to L5) for degenerative and lytic changes •ASA I and II patients.

排除标准

  • Patient refusal
  • bleeding disorder
  • Local infection.
  • Patient who were on chronic drug therapy.
  • Adjacent segment disease requiring surgeries
  • Inflammatory or infective etiology
  • Foreign nationals.

结局指标

主要结局

Requirement of opioid analgesia in the perioperative period

时间窗: At end of 48 hours from start of surgery

次要结局

  • Duration of analgesia(Till when rescue analgesia is given)

研究者

发起方
Hospital administration
申办方类型
Research institution and hospital

研究点 (2)

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