Levobupivacaine versus ropivacaine with fentanyl as an adjuvant for patient controlled epidural labour analgesia- A comparative study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total dose requirement of levobupivacaine and ropivacaine with fentanyl as an adjuvant
研究概览
简要总结
This is interventional randomised study to compare the effect of levobupivacaine and ropivacaine with fentanyl as an adjuvant for patient control epidural labour analgesia in parturient with ASA grade II physical state. It will be conducted in single center in India. The primary outcome measure will be total dose requirement of levobupivacaine and ropivacaine with fentanyl and secondary outcomes will be total number of PCEA demand boluses, total number of manual rescue boluses, extent of sensory block, maternal satisfaction score, mode of delivery, fetal outcome, side effects like hypotension, nausea, vomiting, pruritis , motor blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA physical status II 2.Parturients with cervical dilation <5 cm 3.Nulliparous labouring parturients with singleton pregnancy and vertex presentation who will request labour analgesia.
- •Non stress test of foetus should be normal.
排除标准
- •Any contraindication to neuraxial block like Patient reusal or uncooperative patient Coagulopathy History of allergy to study drugs Skin infection in lumbar region.
- •Patients who had received parenteral opiods <2 hour earlier
- •Parturients with obsterics complications such as multiple pregnancies, prologed labour, PIH,Gestational diabetes, Oligohydromnios, Polyhydromnios, Bad obstetrics history, foetus.
结局指标
主要结局
Total dose requirement of levobupivacaine and ropivacaine with fentanyl as an adjuvant
时间窗: Hemodynamic parameters every 5 minute till 30 minute and every 15 minutes till delivery of fetus
次要结局
- 1. Total number of PCEA demand bolus(2.Total number of manual rescue boluses)