Comparison of Spinal Tetracaine With Fentanyl and Epinephrine Versus Bupivacaine With Fentanyl and Epinephrine for Combined Spinal Epidural Labor Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Spinal Analgesic Duration
研究概览
简要总结
The investigators hypothesis is that spinal tetracaine with fentanyl and epinephrine used for CSE labor analgesia volume will last a significantly longer period of time that that of spinal bupivacaine with fentanyl. After informed consent is obtained for the study, subjects meeting criteria when analgesia is requested will be randomized to receive a combined spinal-epidural containing either tetracaine 2 mg with fentanyl and epinephrine or bupivacaine 2 mg with fentanyl and epinephrine.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •early labor (>=2cm but =<6cm cervical dilation)
- •at least 12 years of age
- •have an assigned ASA physical status 1 or 2
- •singleton pregnancy
排除标准
- •contraindications to neuraxial anesthesia
- •with allergies to drugs used in the study
- •have an assigned ASA status 3 or 4
- •advanced labor (> 6cm cervical dilation)
- •less than 12 years of age
- •Patients with the potential for distorted epidural anatomy, such as Harrington rods or prior back surgery, will also be excluded.
研究组 & 干预措施
tetracaine 2mg
干预措施: Tetracaine (Drug)
Bupivacaine 2 mg
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Spinal Analgesic Duration
时间窗: 1-2 hrs
duration of time in minutes from the time the combined spinal epidural is placed until the participant requests additional analgesia; at that time the epidural was dosed and study participation was complete
次要结局
未报告次要终点