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临床试验/CTRI/2024/07/070616
CTRI/2024/07/070616尚未招募4 期

A Comparative Study to Evaluate Effect Of Preoperative Transdermal Buprenorphine Patch In Orthopedic Surgeries.

GCS medical College Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月25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
60
试验地点
1
主要终点
To compare Efficacy of Transdermal Buprenorphine Patch when Applied 12hr and 24hr before surgery

研究概览

简要总结

postoperative pain is one of the major cause of morbidity in orthopedic surgeries which causes delay in ambulation and discharge so we will  use buprenorphine patch in such patients preoperatively as it has delayed peak onset of action for postoperative pain relief.we will conduct this study in 60 patients.they will be divided in 2 groups randomly. in first group we will apply patch 12hr before surgery and in second group we will apply patch 24hr before surgery.then we will assess patient  for onset of pain ,its severity,any side effect related to patch and compare both the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.ASA status 1,2 patient undergoing replacement surgeries 2.age group 20 to 70 years.

排除标准

  • 1.ASA Status 3,4 2.Patient with coagulopathy 3.patient with allergy to test drug/local anaesthetic 4.patient refusal.

结局指标

主要结局

To compare Efficacy of Transdermal Buprenorphine Patch when Applied 12hr and 24hr before surgery

时间窗: To compare Efficacy of Transdermal Buprenorphine Patch when Applied 12hr and 24hr before surgery

次要结局

  • any side effect assessment(Preoperatively & postoperatively at 1,2,3,4,5,6,12,18,24,36,48,72hr post operatively)

研究者

发起方
GCS medical College Hospital and Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Yash Patel

GCS Medical College Hospital and Research Centre

研究点 (1)

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