Comparison of Combined Spinal-epidural Analgesia Versus Epidural Analgesia During Labor
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Labor duration
研究概览
简要总结
The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.
详细描述
Participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. The investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal Apgar scores, VAS scores, modified Bromage scores.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
One anesthetist who were not involved with clinical care or data collection performed the randomization procedure and the neuraxial block according to the group allocation. The other anesthetist blinds to the procedure preform the analgesia management after neuraxial block. This anesthetist and the obstetrician, the midwives, the patients , the outcomes collector and assessor are all blind to group allocation throughout.
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate.
排除标准
- •Contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications
研究组 & 干预措施
Combined spinal-epidural analgesia
The combined spinal epidural analgesia technique was used to maintain analgesia for parturients in the combined spinal-epidural analgesia group. First, the investigator injected a dose of 5 ug sufentanil into cerebrospinal fluid. If no adverse effects were observed 10 minutes after the first dose, the parturient then received mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate through a patient-controlled epidural analgesia (PCA) pump, which provided patients themixed solution at 8-10ml/h to optimize their pain relief until the delivery of neonates.
干预措施: Combined spinal-epidural analgesia (Procedure)
Epidural analgesia
The epidural analgesia technique was used to maintain analgesia for parturients in the epidural analgesia group, which involved placing a thin catheter through a needle inserted into the epidural space. First, the investigator injected a test dose of 5ml 1% lidocaine through it. If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h to optimize their pain relief until the delivery of neonates.
干预措施: Epidural analgesia (Procedure)
结局指标
主要结局
Labor duration
时间窗: At the end of delivery
Duration of three stages of labor
次要结局
- 1 minute and 5 minutes Apgar scores(1 min after delivery, 5 min after delivery.)
- Visual Analogue Scores(VAS)(At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs； at cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta.)
- Modified Bromage scores(At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs； at the cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta.)
- The mode of delivery(At the end of delivery)
研究者
Deng Dongrui
Professor, Chief doctor
Tongji Hospital