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临床试验/NCT02588417
NCT02588417已完成2 期

Intrathecal Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Combined Spinal Epidural for Vaginal Delivery Analgesia: A Comparative Study.

ahmed elsakka0 个研究点目标入组 80 人开始时间: 2015年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
80
主要终点
duration of spinal analgesia

研究概览

简要总结

To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.

详细描述

This prospective double-blind trial included 80 primigravidas during vaginal delivery with a cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups; Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The primary outcome measure was the duration of spinal analgesia. Secondary outcome measures include time from spinal analgesia to delivery, total amount of epidurally administered levobupivicaine, adverse effects of neuraxial block and neonatal outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA physical status I,II patients schedueled for normal vaginal deliveries
  • age between 18-35 years old

排除标准

  • Patients who refused to participate
  • complicated pregnancies

研究组 & 干预措施

dexamethasone

Active Comparator

dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine

干预措施: Dexamethasone (Drug)

dexamethasone

Active Comparator

dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine

干预措施: Levobupivacaine (Drug)

levobupivacaine

Active Comparator

levobupivacaine 2.5 mg in 2 ml administered intrathecally during active stage of labor once and alone and then epidural levobupivacaine 7ml of 2.5 mg concentrationis administered till the end of labor

干预措施: Levobupivacaine (Drug)

结局指标

主要结局

duration of spinal analgesia

时间窗: 1 day

次要结局

  • time from spinal analgesia to delivery(1 day)

研究者

发起方
ahmed elsakka
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

ahmed elsakka

dr

Kasr El Aini Hospital

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