NCT02665936Unknown2 期
Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study
Kasr El Aini Hospital0 个研究点目标入组 90 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 主要终点
- Duration of epidural analgesia
研究概览
简要总结
The purpose of this study is to detect whether the addition of epidural dexamethasone will prolong labor analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I, II
- •normal vaginal delivery In early active phase of labor
- •singleton cephalic presentation at term
排除标准
- •complicated pregnancies
- •morbid obesity
- •diagnosed fetal abnormalities
- •contra-indications to regional anesthesia
研究组 & 干预措施
group L
Active Comparator
Epidural levobupivacaine 0.125% (Chirocaine) in normal saline in a total volume of 10 ml will be administered epidurally in active stage of labor
干预措施: Levobupivacaine (Drug)
group LD4
Active Comparator
Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 4 mg in a total volume 10 ml
干预措施: Dexamethasone and levobupivacaine (Drug)
group LD8
Active Comparator
Epidural levobupivacaine 0.125%(Chirocaine) in normal saline combined with dexamethasone 8 mg in a total volume 10 ml
干预措施: Levobupivacaine and Dexamethasone (Drug)
结局指标
主要结局
Duration of epidural analgesia
时间窗: an average of 5 months
次要结局
- Time of onset of sensory block at level T10(an average of 5 months)
研究者
ahmed elsakka
m.d. anasthesia
Kasr El Aini Hospital
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