Impact of Injected Volume on Programmed Intermittent Epidural Bolus Analgesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Patient controlled boluses received
研究概览
简要总结
The purpose of this study is to evaluate whether changing the volume and concentration of a medication affects the quality of pain relief and the side effects associated with labor epidural analgesia.
详细描述
This is a randomized, single blinded trial comparing epidural pain relief for labor when medications are delivered in one of two volumes/concentrations. Patients in each arm of the study will receive the same dose of medication, but one will be half as concentrated and twice the volume. The outcome will be the number of supplemental doses of medication that patients receive during labor via their patient-controlled analgesia button.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Gestational age of 36 weeks or greater
- •American Society of Anesthesiology physical status 2
- •Induction of labor or early labor (cervical dilation < 6cm)
- •Singleton gestation
- •Vertex presentation
排除标准
- •Preeclampsia
- •Receiving magnesium sulfate
- •Having received narcotics within 4 hours
- •Multiple gestation
- •Major fetal anomalies or demise
- •Previous spine surgery
- •Known major spine pathology
- •Substance use disorder
结局指标
主要结局
Patient controlled boluses received
时间窗: The duration of labor until delivery of the neonate
The number of patient-controlled boluses received by the patient by pressing the patient-controlled analgesia (PCA) button for additional pain relief
次要结局
- Patient controlled boluses requests(The duration of labor until delivery of the neonate)
- Physician administered epidural bolus(The duration of labor until delivery of the neonate)
研究者
Phillip Hess
Principle investigator
Beth Israel Deaconess Medical Center