Combined Spinal-Epidural Versus Traditional Labor Epidural: A Randomized, Controlled Trial Comparing Maternal and Fetal Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns
研究概览
简要总结
The purpose of this study to compare the use of spinal-epidural versus traditional labor epidural on maternal and fetal effects. The hope is to determine the safest and most effective epidural method of relieving pain during labor.
详细描述
Combined spinal-epidural anesthesia (CSE) was developed to allow excellent pain control for the pregnant woman who arrives in advanced labor and does not have much time for the anesthetic to have its effect. This has been extended recently to women in all stages of labor because of its rapid and excellent control of pain. Recent case series comparing CSE with traditional epidural have shown a slight difference in the rate of hypotension and fetal bradycardia, with the CSE technique having a higher rate of both of these side effects. This study will compare the two techniques in a prospective, randomized method.
The aim is to compare the maternal and fetal effects of two neuraxial block techniques for pain control during labor, to document blood pressure changes in upper and lower extremities pre- and post- block placement, and to document side effects (e.g. pruritus) and patient satisfaction with both 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient is able to read, understand and voluntarily sign the approved informed consent form (ICF) prior to any study- specific procedure;
- •Must be between 18 to 50 years of age.
- •Must be carrying a singleton fetus at term.
- •Must have less than a body mass index of
- •Must be in labor, or is having a medical induction of labor.
排除标准
- •Patient who has chronic renal disease, pre-existing hypertension, or pre-eclampsia.
- •Patient who is undergoing an elective cesarean delivery
- •Patient who has a presence of non-reassuring fetal status
- •Patient who has an abnormal or non-reassuring fetal heart rate (FHR) pattern
研究组 & 干预措施
CSE
Subjects assigned to this group will receive "combined spinal-epidural" (CSE) to relieve pain during labor. For CSE, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer directly into the spinal canal (a smaller amount than is given for traditional epidural), followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. CSE is not experimental.
干预措施: Bupivacaine and Fentanyl (for CSE) (Drug)
Traditional Epidural
Subjects assigned to this group will receive "traditional epidural" to relieve pain during labor. For the traditional epidural, subjects receive a small amount of a local anesthetic and a small amount of a narcotic pain killer into the epidural space, followed by a small amount of both of these medications that is continuously infused into the epidural space through a catheter that is left in place. The traditional epidural is not experimental.
干预措施: Bupivacaine and Fentanyl (for traditional epidural) (Drug)
结局指标
主要结局
Adverse fetal effects: fetal bradycardia and abnormal fetal heart rate patterns
时间窗: during the 60 minutes after placement of analgesia
次要结局
- Average change in systolic blood pressure(during the 60 minutes after placement of analgesia)
- Average change in mean blood pressure(during the 60 minutes after placement of analgesia)
- Blood pressure differences between the upper and lower extremities(during the 60 minutes after placement of analgesia)
- Efficacy of analgesia as rated by the visual analog pain scale(during the 60 minutes after analgesic placement)
- Pruritus(through the first day following placement of analgesia)
- Incidence of hypotension(during the 60 minutes after placement of analgesia)
- Patient satisfaction(first day following placement of analgesia)