Comparative evaluation of transdermal buprenorphine and transdermal fentanyl for Postoperative Pain Relief after gynaecological Surgeries – a prospective randomized study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- To compare the postoperative analgesic efficacy between transdermal buprenorphine and transdermal fentanyl after gynecological surgeries using a visual analog scale (VAS) at rest and movement.
研究概览
简要总结
This study is a prospective randomized study comparing evaluation of transdermal buprenorphine and transdermal fentanyl for postoperative pain relief after gynaecological surgeries that will be conducted in Melmaruvathur adhiparasakthi institute of medical sciences and research. Primary outcome will be postoperative analgesic efficacy between the groups. Secondary outcome will be time to rescue analgesia between the groups, total amount of rescue analgesic consumption, hemodynamic parameters( heart rate, respiratory rate,systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation) and anticipated side effects between groups in post operative period from first to seventy second hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women (Age-18 – 60 ).
- •ASA classes I to III.
- •Those posted for transabdominal gynecological surgeries performed with pfannenstiel incision.
排除标准
- •History of allergy to opioids.
- •History of ongoing drug/ alcohol abuse.
- •Patients who are already using a transdermal opioid patch, dependence on opioids.
- •Pregnant patients.
- •Combined epidural block.
- •Patients with abnormal liver or renal function.
结局指标
主要结局
To compare the postoperative analgesic efficacy between transdermal buprenorphine and transdermal fentanyl after gynecological surgeries using a visual analog scale (VAS) at rest and movement.
时间窗: Visual analog scale (VAS) at rest is recorded at postoperative period of 1st,1.5th,2nd,4th,6th,8th,10th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th,72nd hours. | Visual analog scale (VAS) at movement is recorded at postoperative period of 24th,28th,32nd,36th,40th,44th,48th,72nd hours.
次要结局
- To compare the total amount of rescue analgesic consumption in the postoperative period.(postoperative period from 1st to 72nd hours)
- To compare the time to rescue analgesia between the groups.(Postoperative period from 1st to 72nd hours.)
- To compare hemodynamic variations such as heart rate (HR), Respiratory rate (RR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (SPO2) between the groups.(preoperative period (baseline),postoperative period at 1st,1.5th,2nd,4th,6th,8th,10th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th,72nd hours.)
- To compare the side effects between the groups.(postoperative period from 1st to 72nd hours.)