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临床试验/CTRI/2019/02/017417
CTRI/2019/02/017417已完成不适用

A study to compare the safety and efficacy of two different strengths of transdermal buprenorphine for the treatment of post-operative pain following surgery for proximal femoral fracture

Department of anaesthesiology Pt B D Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年8月2日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Visual analogue scale (VAS)

研究概览

简要总结

I am conducting a study to compare the safety and efficacy of two different strengths of transdermal buprenorphine for the treatment of post-operative pain following surgery for proximal femoral fracture.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • of patients- 75 ASA- I to III Patients undergoing surgery for proximal femoral fractures under spinal anesthesia.

排除标准

  • Patients having poly trauma with any other fracture, Obese, hepatic or renal impairment, myasthenia gravis, delirium tremens, skin allergy.

结局指标

主要结局

Visual analogue scale (VAS)

时间窗: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day

Post operative nausea and vomiting(PONV)

时间窗: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day

Rescue analgesia

时间窗: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day

Complications

时间窗: Visual analogue scale (VAS) at 2 hrs,4 hrs,6 hrs,12 hrs,24 hrs,3rd day,5th day,7th day | Post operative nausea and vomiting(PONV) at 2 hrs,4 hrs,6 hrs 12 hrs,24 hrs,3rd day, 5th day 7th day | Rescue analgesia at 1st,2nd,3rd,4th,5th,6th,7th day | Complications at 1st,2nd,3rd,4th,5th,6th,7th day

次要结局

  • Heart rate(Mean arterial pressure)

研究者

发起方
Department of anaesthesiology Pt B D Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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