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临床试验/CTRI/2024/10/075613
CTRI/2024/10/075613尚未招募不适用

A Comparative study between transdermal patches of buprenorphine and fentanyl for post operative analgesia following infraumbilical surgeries under regional anaesthesia

GOA MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
To see whether fentanyl or buprenorphine transdermal patch is a good analgesic

研究概览

简要总结

Patients will be randomly divided into 2 groups.

• Transdermal patch will be applied 12 hours prior to the surgery.

• Buprenorphine patch of 10mg releasinf buprenorphine at the

rate of 10mcg/hr and fentanyl patch of 3mg releasing fentanyl

at the rate of 25mcg /hr will be used.

• For induction, spinal anaesthesia with 3cc of 0.5% heavy

bupivacaine will be given . No adjuncts will be added.

• Intraoperatively,pulse, noninvasive blood pressure,ECG and

SpO2 will be monitored at every 15 minutes interval.

• Post operatively, pulse , blood pressure and respiratory rate ,

total duration of analgesia, requirement of rescue analgesic(iv

paracetamol 1 gm) and side effects like nausea ,vomiting

,pruritis, sedation and respiratory depression will be noted for

3 days.

• Patients will be explained about Visual Analogue Scale (VAS),

which is a 10cm scale, where in

0:No pain

1-3:mild pain

4-7:moderate to severe pain

8-9:very severe pain

10:worst pain ever

Statistical analysis:Data collected will be analyzed using the latest

SPSS software to find out clinical and statistical

significance. A p value of <0.05 will be considered

as statistically significant.

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
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 21 years to 60 years giving informed consent ASA I and II.

排除标准

  • Patients allergic to buprenorphine and fentanyl Pregnancy.

结局指标

主要结局

To see whether fentanyl or buprenorphine transdermal patch is a good analgesic

时间窗: 12 hrs | 3 days

次要结局

  • To compare whether transdermal fentanyl or buprenorphine patch is associated with more side effects(12 hrs)

研究者

申办方类型
Government medical college

研究点 (1)

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