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临床试验/CTRI/2019/03/017964
CTRI/2019/03/017964尚未招募4 期

Comparison of Preoperative Ultrasound guided Fascia iliaca block versus Femoral nerve block for proximal femur fractures before positioning for spinal anaesthesia – an observational study

Meeta Gupta2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年11月3日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
2
主要终点
intraoperative hemodynamics ( Heart rate, Mean arterial pressure at 5,10 and 15 minutes) between the two groups.

研究概览

简要总结

This study is a comparative observational two centre trial, comparing the preoperative ultrasound guided fascia iliaca block versus femoral nerve block in proximal femur fractures before positioning for spinal anesthesia that will be conducted in two centres in India.The primary outcome measures will be level of pain relief by (VAS score) before positioning for spinal  anesthesia ( baseline and at 1, 2, 3, 4 ,5, 10, and 15 minutes) and intraoperative hemodynamics ( heart rate and mean arterial pressure) at 5,10 and 15 minutes between the two groups. The secondary outcomes will be duration of pain relief postoperatively (rescue analgesia)  by VAS score at 2,4,8,12,16,20 and 24 hours and  total analgesic requirement between the two groups in the next 24 hours .

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status I, II ,III and Emergency patients.
  • Planned for proximal femur fracture fixation.

排除标准

  • Patient’s refusal History of allergy to local anaesthetics Coagulopathy or Bleeding diathesis H/o peripheral neuropathy Previous femoral bypass surgery Inguinal hernia Local skin infection.

结局指标

主要结局

intraoperative hemodynamics ( Heart rate, Mean arterial pressure at 5,10 and 15 minutes) between the two groups.

时间窗: March 15,2019 to December 15,2019

level of pain relief by (VAS score) before positioning for spinal anaesthesia ( baseline,at 1,2,3,4,5,10and 15 minutes) between the two groups.

时间窗: March 15,2019 to December 15,2019

次要结局

  • To compare the duration of pain relief postoperatively (rescue analgesia) by VAS score at 2,4,8,12,16,20 and 24 hrs between the two groups.(To compare the total analgesic requirement in the next 24 hours between the two groups.)

研究者

发起方
Meeta Gupta
申办方类型
Other [Principal investigator]

研究点 (2)

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