Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Maternal Outcomes
研究概览
简要总结
The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief.
The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.
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)
盲法说明
Anesthesiologist performing technique and bedside nurse instructed not to reveal randomization arm to the patient or study co-investigator who was waiting outside the room, and notified only after completion of the neuraxial placement protocol.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous (first baby) parturient
- •Singleton, vertex gestation at term (37-42 weeks)
- •Less than 5 cm dilation
- •Desires an epidural technique for labor analgesia
排除标准
- •Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
- •Any contraindication to the administration of an epidural technique
- •History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications
- •Current or historical evidence of a disease which may result in the risk of a cesarean delivery.
- •Evidence of anticipated fetal anomalies
研究组 & 干预措施
Epidural Technique
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
干预措施: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique (Procedure)
Combined Spinal Epidural Technique
Bupivacaine 2.5 mg with Fentanyl 25 mcg
干预措施: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique (Procedure)
Dural Puncture Epidural Technique
Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min
干预措施: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique (Procedure)
结局指标
主要结局
Maternal Outcomes
时间窗: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis.
次要结局
- Fetal Outcomes(Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours)
研究者
Lawrence Ching Tsen
Associate Professor, Harvard Medical School
Brigham and Women's Hospital