Intrathecal Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Combined Spinal Epidural for Vaginal Delivery Analgesia: A Comparative Study.
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
- 否
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
dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine
干预措施: Dexamethasone (Drug)
dexamethasone
dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine
干预措施: Levobupivacaine (Drug)
levobupivacaine
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
ahmed elsakka
dr
Kasr El Aini Hospital
