CTRI/2016/06/007039已完成3 期
A Comparative Study of ropivacaine with fentanyl and bupivacaine with fentanyl for postoperative epidural analgesia after major abdominal oncosurgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- VAS score for postoperative pain
研究概览
简要总结
This is a prospective, randomized, double blind ,parallel group, active controlled, single centric interventional trial comparing the analgesic efficacy of epidural ropivacaine with fentanyl and bupivacaine with fentanyl after major abdominal oncosurgery at fixed time points in 60 patients of either sex at Rajiv Gandhi Cancer Institute and Research Centre.VAS Sore for postoperative pain relief is the primary outcome measure and Bromage Score for motor blockade is the secondary outcome measure at various time points of 10 minutes, 1hour, 6 hours, 12 hours, 18 hours and 24 hours postoperatively
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Weight between 45-75 Kg ASA Physical Status I, II and III Elective major oncosurgery via a vertical, midline infraumbilical incision.
排除标准
- •Patient refusal for Regional Anaesthesia Contraindications for Regional Anaesthesia(coagulopathy,regional infection) History of allergic reaction to Bupivacaine, Ropivacaine or Fentanyl Spinal deformity.
结局指标
主要结局
VAS score for postoperative pain
时间窗: 10mins,1hour,6hour,12hour,18 hour and 24 hour
次要结局
- Bromage Score for motor blockade(10 mins,1hour,6 hours,12 hours,18 hours and 24 hours)
研究者
研究点 (1)
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