跳至主要内容
临床试验/CTRI/2019/04/018477
CTRI/2019/04/018477尚未招募3 期

Effectiveness of erector spinae block for pain relief in patients going to have surgery for kidney stones

Department of anaesthesia and intensive care1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月4日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To evaluate the reduction in pain intensity up to 24 hours in post-operative period by the use of visual analogue scale in patients receiving erector spinae plane block after percutaneous nephrolithotomy.

研究概览

简要总结

Ultrasound guided erector spinae plane (ESP) block is a regional anaesthesia technique, recently described by Forero et al for use in thoracic neuropathic pain. In ESP block, the local anaesthetic is injected, using ultrasound guidance, deep to erector spinae muscle group and superficial to a thoracic transverse process, resulting in extensive deep and superficial spread that lead to analgesic effect on somatic and visceral pain by effecting the ventral rami and rami communicants that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.

Besides the anecdotal case reports regarding the use of erector spinae plane block in various situations, the review of literature could not disclose any randomised control trial with respect to ESPB in PCNL. Hence the present study has been designed to evaluate the efficacy of erector spinae plane block in providing post- operative analgesia to patient undergoing PCNL in comparison to well established technique of IV PCA.

In the proposed study, ESPB will be performed at the level of T12 in prone position post operatively before extubation of patient, in interventional group, who underwent PCNL. Post extubation patient will be attached to IVPCA morphine pump. VAS score will be used as tool to assess the severity of pain.

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
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • American society of anaesthesiologists (ASA) physical status I-II
  • Age 18-65 years
  • BMI >18.5 to >25
  • Patient undergoing Percutaneous nephrolithotomy.

排除标准

  • History of relevant drug allergy
  • Patient refusal
  • History of psychiatric illness, substance abuse or medical therapies resulting in tolerance to opioids 4.Severe cardiovascular, respiratory, metabolic or neurologic disease.
  • Pregnancy
  • Untreated sepsis
  • Local infection
  • Severe coagulopathy (PTI<70% / INR>1.5)
  • Complex stone with anticipation of requiring >1 access site.
  • Prior diagnosis of chronic pain requiring daily opioid analgesic for >1 month prior to diagnosis of nephrolithiasis.
  • Back or other musculoskeletal deformity that contributes to inaccuracy of the block placement.
  • Fibromyalgia.

结局指标

主要结局

To evaluate the reduction in pain intensity up to 24 hours in post-operative period by the use of visual analogue scale in patients receiving erector spinae plane block after percutaneous nephrolithotomy.

时间窗: 10 mins, 30 mins, 1hr, 4hrs, 8 hrs, 12hrs, 24hrs

次要结局

  • To calculate and compare the total opioid consumption over 24 hours in erector spinae plane block group as well as control group(24 hrs)
  • To calculate and compare the total dose of antiemetics over 24 in erector spinae plane block group as well as control group(10 mins, 30 mins, 1hr, 4hr, 8hr, 12hr, 24hr)
  • To note any side effects pertaining to the procedure or the drugs used in the present study(10 mins, 30 mins, 1hr, 4hrs, 8hrs, 12hrs, 24hrs)

研究者

发起方
Department of anaesthesia and intensive care
申办方类型
Government medical college

研究点 (1)

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