跳至主要内容
临床试验/CTRI/2022/04/041580
CTRI/2022/04/041580招募中Unknown

To compare the efficacy of two different approaches of Interscalene Brachial Plexus Block in patients undergoing arthroscopic shoulder surgery.

Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年9月4日最近更新:

试验速览

阶段
Unknown
状态
招募中
入组人数
42
试验地点
1
主要终点
To study and compare analgesia following interscalene brachial plexus block (classic Vs low)

研究概览

简要总结

We undertake this study to compare the both techniques of intercalene brachial plexus block - classical approach (in the inter scalene groove at the level of C6) with the low approach (block at the site about 2/3rd of the distance caudally from C6) with aid of both USG and PNS to evaluate the analgesic efficacy, safety, sensory and motor block as well as to find out the proximal drug spread (to cervical plexus with aid of sensory dermatomal testing) & distal drug spread (to supraclavicular region with aid of regional fluoroscopy).

 In this study, we will also compare the block characteristic like performance time, onset time, complications, sensory, motor block, procedural pain, operator experience, no. of time needle passes, analgesic efficacy, pain score, complication, assessment of motor strength & patient’s satisfaction.

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

  • Adult patients (18-65 years) of either sex
  • American Society of Anaesthesiology Physical Status ( ASA) Grade I/II with BMI b/w 20-35 kg/m2
  • Patients scheduled to undergo unilateral arthroscopic shoulder surgery
  • Patients can understand and comply with the study instructions.

排除标准

  • Patients with preexisting obstructive / restrictive lung diseases or preexisting hemi diaphragmatic dysfunction.
  • BMI > 35 kg/metre2
  • History of known local anesthetic allergy
  • History of neurological deficit in upper limbs
  • History of coagulopathy
  • Local site Infection
  • Pregnancy
  • Hepatic/ renal failure.

结局指标

主要结局

To study and compare analgesia following interscalene brachial plexus block (classic Vs low)

时间窗: Baseline, intra-operatively, post block upto 24 hours

次要结局

  • To study and compare incidence of block characteristics (sensory-motor blockade, radiological spread, number of needle passes), respiratory functions, patient satisfaction and complications, if any.(Peri-operative monitoring of the block characteristics (sensory-motor blockade, radiological spread, number of needle passes), respiratory functions, patient satisfaction and complications)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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