Superiority of Epidural Placement Technique Using EpiFaith® Syringe Versus Conventional Glass Syringe in Laboring Paturients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Success of epidural localization
研究概览
简要总结
The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.
详细描述
We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Females 18 years of age and older at screening
- •Request labor epidural analgesia
- •Able to give informed consent to participate in the study
- •American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status
- •BMI ≤ 40 kg/m2
排除标准
- •BMI > 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)
- •Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks
- •Any allergy to bupivacaine or fentanyl
结局指标
主要结局
Success of epidural localization
时间窗: 30 minutes
Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture
次要结局
未报告次要终点
研究者
Jie Zhou
Assistant Professor
Harvard Medical School (HMS and HSDM)