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临床试验/CTRI/2020/01/022915
CTRI/2020/01/022915尚未招募4 期

Comparison between intermittent Epidural bolus and continuous Epidural infusion of 0.1% levobupivacaine and fentanyl combination for labor analgesia.

Department of anaesthesiology and intensive care1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年1月27日最近更新:

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.)

研究者

发起方
Department of anaesthesiology and intensive care
申办方类型
Government medical college

研究点 (1)

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