Comparison between intermittent Epidural bolus and continuous Epidural infusion of 0.1% levobupivacaine and fentanyl combination for labor analgesia.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Level of analgesia
研究概览
简要总结
The present randomized study will be conducted on 80 women in labour, belonging to ASA grade I or II, more than 36 weeks of gestation, at 3- 5 cm cervical dilatation, single pregnancy with cephalic presentation, who requested for labour analgesia at Rajindra Hospital, Patiala. The patients will be allocated randomly to 2 groups. Group A: Parturient will be given 10 ml of 0.1% Levobupivacaine (plain ) with Fentanyl 50 mcg and then 8 ml of 0.1% Levobupivacaine (plain ) and fentanyl 2 mcg / ml solution as epidural bolus every hour. Group B: Parturient will be given 10 ml of 0.1% levobupivacaine (plain ) with fentanyl 50 mcg and then 8 ml /hour of 0.1% Levobupivacaine (plain ) with fentanyl 2 mcg / ml as continuous epidural infusion. After administration of the drug,pain intensity, level of sensory block, degree of motor block, total drug requirement ,hemodynamic variables, mode of delivery, duration of second stage,neonatal outcome and side effects and post partum complications will be compared in both the groups.
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
- 20.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •parturient with single pregnancy.
- •Cervical dilatation of 3-5 cm.
- •Cephalic presentation Gestation >37 weeks.
排除标准
- •Breech presentation Antepartum Haemorrhage Severe Pre eclampsia Multiple pegnancies Cephalopelvic disproportion Bleeding disorders Decreased platelet counts Sepsis Aortic stenosis Diabetes Fetal distress Imminent delivery spinal column deformity Spine surgery Contraindication to epidural analgesia History of anaphylaxis to local anaeshetics and allergy to drug to be administered.
结局指标
主要结局
Level of analgesia
时间窗: Till the time of delivery of the baby.
次要结局
- Total drug requirement ,Mode of delivery, Postpartum complications(48 hours after delivery.)
