To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesia
研究概览
简要总结
This study is conducted to evaluate and compare the minimum local analgesia concentration ( MLAC) of epidural levobupivacaine with fentanyl in patients receiving combined spinal epidural labour analgesia with intrathecal fentanyl with and without levobupivacine. We have included primigravida with full term pregnancy with cephalic presentation in active induced labour. We would like to evaluate whether addition of levobupivacaine intrathecally with fentanyl has an synergistic effect on reducing the MLAC of levobupivacaine with fentanyl epidurally and does it affect the course, quality of analgesia and maternal and fetal outcome of labour.
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
- •1.Primigravida women requesting labour analgesia with full term gestation 36-40 weeks, singleton pregnancy with cephalic presentation having American Society Of Anesthesiologists physical status II 2.Patients giving valid informed consent.
- •3.Patients in active stage of induced labour with cervical dilatation of 4-5 cm at the time of epidural catheter placement.
排除标准
- •1.Patient refusal 2.Gestational age >36 weeks with malpresentation/ multiple gestation.
- •3.Patients with PIH / Eclampsia.
- •4.Patients who have received IV/ IM opioids within 4 hours of epidural insertion.
- •5.Entered in second stage of labour.
- •6.Delivery within 30mins of intrathecal analgesia.
- •7.Delivery without the requirement of epidural top up.
- •8.Failure to obtain VAS<2 after 15minutes of intrathecal drug injection.
- •9.Patient with motor block higher than T4 dermatomal level at any time post procedure suspecting intrathecal epidural catheter insertion.
- •10.Inadvertent dural puncture during epidural space localization.
结局指标
主要结局
To evaluate and compare epidural minimum local analgesic concentration of levobupivacaine with fentanyl in patients receiving intrathecal fentanyl with and without levobupivacaine for labour analgesia
时间窗: During labour analgesia
次要结局
- Duration of intrathecal analgesia(quality of analgesia)