Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The most severe labor pain score during labor
研究概览
简要总结
Neuraxial analgesia is the gold standard to relieve labor pain. A recent "Practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation < 5 cm) or on a individualized basis. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.
详细描述
Neuraxial analgesia is the gold standard to relieve labor pain. It also helps to attenuate maternal anxiety and improve maternal satisfaction. A recent "Practice guidelines for obstetric anesthesia" suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation < 5 cm) or, for some special patients, be provided on a individualized basis. Studies showed that, when compared with late administration, early administration of labor analgesia resulted in equivocal findings for spontaneous, instrumented, and cesarean delivery. The investigators hypothesize that neuraxial labor analgesia provided on an individualized basis will further improve analgesia quality and maternal satisfaction. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.
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
- None
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparas (aged 18-36 years) with single cephalic term pregnancy;
- •Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians;
- •Admitted to the delivery room;
- •Agree to receive epidural analgesia during labor.
排除标准
- •History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
- •Presence of contraindications to epidural analgesia, which includes: (1) History of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) History of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) Systemic infection (sepsis); (4) Skin or soft tissue infection at the site of epidural puncture; (5) Coagulopathy.
- •Other reasons that are considered unsuitable for study participation.
研究组 & 干预措施
Individualized epidural analgesia
Epidural catheterization will be performed after the beginning of the first stage of labor. Epidural analgesia will begin when asked by parturients and the numeric rating scale of pain is 5 or higher. A loading dose (10 ml mixture of 0.1% ropivacaine and 0.5 ug/ml sufentanil) will be administered through the epidural catheter. After a 20-minute observation, a patient-controlled analgesia pump (containing a mixture of 0.08% ropivacaine and 0.4 ug/ml sufentanil) will be connected to the epidural catheter and programmed to deliver a 6-ml bolus with a 20-minute lockout interval and a 4 ml/h background infusion. Analgesia will be terminated at the end of the third stage of labor.
干预措施: Individualized epidural analgesia (Drug)
Routine epidural analgesia
Epidural catheterization will be performed after the beginning of the first stage of labor and the cervix is dilated to 1 cm or more. Epidural analgesia will then begin. A loading dose (10 ml mixture of 0.1% ropivacaine and 0.5 ug/ml sufentanil) will be administered through the epidural catheter. After a 20-minute period observation, a patient-controlled analgesia pump (containing a mixture of 0.08% ropivacaine and 0.4 ug/ml sufentanil) will be connected to the epidural catheter and programmed to deliver a 6-ml bolus with a 20-minute lockout interval and a 4 ml/h background infusion. Analgesia will be terminated at the end of the third stage of labor.
干预措施: Routine epidural analgesia (Drug)
结局指标
主要结局
The most severe labor pain score during labor
时间窗: Assessed at 24 hours after delivery
Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.
次要结局
- Incidence of instrumental delivery(At the time of delivery)
- Neonatal Apgar score(At 1 and 5 minutes after delivery)
- Maternal satisfaction with labor analgesia(Assessed at 24 hours after delivery)
- Persistent pain score at 24 hours and 42 days after delivery(At 24 hours and 42 days after delivery)
- Rate of breast-feeding(At 24 hours and 42 days after delivery)
- Incidence of Cesarean delivery(At the time of delivery)
- Incidence of postpartum depression(At 42 days after delivery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Peking University First Hospital