Determination of the 90% Effective Volume (ED90) of Epidural 0.1% Ropivacaine and Fentanyl for Labor Analgesia Initiation in Patients Receiving a Dural-Puncture Epidural Technique
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Numerical Pain score
研究概览
简要总结
This study is being done to determine the most effective dose of medicine to use to initially provide effective pain relief within the first 30 minutes of receiving an epidural for pain labor during labor. The study team will also study any side effects related to the epidural medication and patients' satisfaction with the quality of pain relief after receiving the epidural.
详细描述
We aim to perform a prospective observational study in a single cohort of 50 patients receiving a dural-puncture epidural technique for labor analgesia. We will use a biased-coin up-down allocation methodology to quantify the volume of a combined epidural 0.1% ropivacaine and 2 mcg/ml fentanyl regimen that achieves effective analgesia in 90% of patients experiencing active labor who receive a dural-puncture epidural technique for labor analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with singleton vertex pregnancies in active labor (latent or spontaneous labor or after induction of labor)
- •Cervical dilatation between 2 and 7 cm
- •Requesting neuraxial labor analgesia
- •Age 18 or older
排除标准
- •Significant obstetric disease (e.g., pre-eclampsia, major cardiac disease)
- •Chronic pain or chronic opioid use
- •Multiple gestations
- •Allergy or anaphylaxis to local anesthetic
- •Fetal compromise or non-reassuring fetal trace
- •Age under 18
- •Inability to speak and understand English or Spanish
研究组 & 干预措施
Observational Cohort
Patients with singleton vertex pregnancies in active labor (spontaneous or after induction of labor), with a cervical dilatation between 1 and 7cm who are requesting neuraxial labor analgesia, Age =>18 yrs
干预措施: Ropivacaine + Fentanyl (Drug)
结局指标
主要结局
Numerical Pain score
时间窗: 30 mins post-intervention
Numerical pain score using a discrete range from 0 (no pain) to 10 (most severe pain).
次要结局
未报告次要终点