CTRI/2014/06/004698已完成4 期
Study of epidural fentanyl 50ug with bupivacaine in cesarean section.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The primary outcome is intraoperative VAS score.
研究概览
简要总结
This is randomized, parallel group double blind study to study to effect of addtion of low dose fentanyl (50ug) to epidural 0.5%bupivacaine in 64 patients undergoing elective cesarean section. The primary outcome is to assess the quality of analgesia and duration of postoperative analgesia. The secondary outcome were to assess fentanyl related side effects, intraoperative haemodynamic changes, onset of analgesia, volume of drug required to achieve T6 level, quality and duration of motor block and adverse events in newborn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- Female
入选标准
- •Full term patients undergoing elective cesarean section.
排除标准
- •Foetal distress, moderate to severe PIH, Patients refusal, conversion to general anaesthsia.
结局指标
主要结局
The primary outcome is intraoperative VAS score.
时间窗: Immediately after completion of surgery VAS score will be assessed.
次要结局
- The secondary outcome were the fentanyl related side effects, intraoperative haemodynamic changes, onset of analgesia, volume of drug required to achieve T6 level, quality and duration of motor block and adverse events in newborn.(till first analgesic demand)
研究者
研究点 (1)
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