Comparison of Epidural Boluses of 0.08%Levobupivacaine and 0.1% RopivacaineUsing Fentanyl as an Adjuvant forLabour Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mode of delivery
研究概览
简要总结
this study was aimed to assess the efficacy of two local anaesthetic agents ( levibupivacaine and ropivacaine) for labour analgesia. We aimed to assess the mode of delivery, analegesia score, patient satisfaction score and complications, if any.
it is a double blinded study and randomization was done by computer generated number, ealed envelope technique.
epidural catheter was placed at the first stage of labour and epidural activated with the repective study drug.
patient was monitored for analgesia, motor blockade and hemodynamics.
study ended with delivery of baby.
Results
Mode Of Delivery**:** In Levobupivacaine (n=35),4 parturients underwent Cesarian section (11.4%) and in Ropivacaine group(n=35), 13 underwent Cesarian section (37.1%) which was statisticallysignificant (p=0.012)
Instrumentation Among Vaginal Delivery : In Levobupivacaine Group, out of the 31Vaginal deliveries, two had Instrumentation (6.45%). In Ropivacaine group, outof the 22 Vaginal deliveries, one underwent Instrumentation (4.54%) which wasstatistically not significant (p=0.739)
Hemodynamics , baby apgar, maternalsatisfaction were comparable in both groups with no side effects
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 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravida with singleton pregnancy 2) Willing to involve in this study 3) Age between 18years to 30years.
- •Categorized under ASA PS I & II.
排除标准
- •Patient refusal 2)High risk pregnancy 3)Primigravida with CPD 4)With fetal anomaly 5)Allergic to local anaesthetics 6)Injection site infection 7)Spine abnormalities 8)Significant coagulopathies.
结局指标
主要结局
Mode of delivery
时间窗: time of delivery
次要结局
- 1. Hemodynamic ( SpO2, MAP, PR, FHR)(2. Foetal outcome)