跳至主要内容
临床试验/CTRI/2018/05/013587
CTRI/2018/05/013587已完成不适用

Comparative Evaluation Of Ultrasound Guided Supra Inguinal Versus Infra Inguinal Approach To Fascia Iliaca Compartment Block – A Randomised Clinical Trial

Mahatma Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
2) quadriceps muscle strenght

研究概览

简要总结

Afterobtaining approval from the institutional ethical committee and obtainingpatient consent, 60 patients schedule for lower limb surgeries ( fulfillinginclusion criteria ) will be recruited for this study.

After the initial assessment, patient willbe randomised based on the allocation number using closed envelope technique.Patient will be prepared for the FICB procedure and the distance from supra- inguinaland infra- inguinal injection points from the ligament will be measured usingultrasound.

Patientwill be continuously monitored and hemodynamic parameters recorded every 10 minutes.The motor and sensory  assessment afterthe block, will be done by the examiner blinded to the approach used for FICB. Sensoryassessment will be done at 30, 45 and 60 minutes after block

A successful 3 nerve block is consideredwhen the sensory assessement score for cold sensation is 0 and motor powerscore for quadriceps and adductor muscles is 1-0 and 50% decrease in pressuregenerated by adductor squeeze test at the end of 60 minutes after block.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor 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

  • •ASA I – II 2) All surgeries requiring FICB for analgesia.

排除标准

  • •Patient refusal 2) Lower limb fracture 3) Patients allergic to local anaesthetics 4) Patients with coagulopathy 5) Patients with neurological deficits and neuromuscular diseases 6) Patients with infection at the site of injection 7) Pregnant patients.

结局指标

主要结局

2) quadriceps muscle strenght

时间窗: outcome will be assessed every 15 minutes for one hour

Incidence of 3 nerves block -

时间窗: outcome will be assessed every 15 minutes for one hour

1) sensory Blockade

时间窗: outcome will be assessed every 15 minutes for one hour

3) adductor squeeze test

时间窗: outcome will be assessed every 15 minutes for one hour

次要结局

  • 1) Time of onset of block of all three nerves(2) Distance between Supra- inguinal and Infra – inguinal injection points from inguinal ligament)

研究者

申办方类型
Private medical college

研究点 (1)

Loading locations...

相似试验

Comparison of local anaesthetic drug injection at... | 临床试验