NCT03980951已完成不适用
A Randomized Comparison of Epidural, Dural Puncture Epidural and Combined Spinal Epidural Without Intrathecal Opioids for Labor Analgesia.
Wahba bakhet2 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- epidural Local anesthetic consumption
研究概览
简要总结
The primary outcome of this clinical trial is to compare the pain scores during labour and delivery of combined spinal epidural without intrathecal opioids and dural puncture epidural
The secondary objective of this study is to compare the and fetomaternal outcomes
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous parturient
- •Singleton, vertex gestation at term (37-42 weeks)
- •Less than 5 cm dilation
- •request an epidural technique for labor analgesia
排除标准
- •Hypersensitivity to local the study drugs
- •Clinically significant disease , including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
- •Any contraindication to the administration of an epidural technique
- •Risk factor for cesarean delivery.
- •fetal anomalies
研究组 & 干预措施
combined spinal epidural group
Active Comparator
Bupivacaine 2.5 mg
干预措施: Combined Spinal Epidural without intrathecal opioids (Procedure)
dura puncture epidural group
Active Comparator
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
干预措施: Dural Puncture Epidural Technique (Procedure)
epidural
Active Comparator
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 20 mL load over 5 min
干预措施: epidural (Procedure)
结局指标
主要结局
epidural Local anesthetic consumption
时间窗: 1 year
次要结局
- incidence of fetal bradycardia(1 year)
- Maternal hypotension(1 year)
- incidence of maternal pruritus(1 year)
- labour pain scores(1 year)
研究者
Wahba bakhet
Director
Ain Shams University
研究点 (2)
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