Epidural Loading Prior to Catheter Insertion: An Alternative to the Combined Spinal-epidural Technique?
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Administration Methods of Labor Analgesia
- 发起方
- Ohio State University
- 试验地点
- 1
- 主要终点
- Mean VAS pain score
- 状态
- 撤回
- 最后更新
- 4年前
概览
简要总结
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists.
详细描述
This study explores the potential for a more rapid onset of pain relief when drug administration is performed through the epidural needle, a technique of epidural loading that provides a rapid and reliable level of labor analgesia without the disadvantages of a combined spinal-epidural, and could add a valuable new tool to anesthesiologists. Investigators propose to conduct a single blinded, randomized controlled trial to determine if a difference exists in the speed of onset and spread of labor analgesia between patients receiving an epidural loading dose through the epidural needle or catheter. Group 1 (Epidural Catheter Administration) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural catheter following catheter placement (current standard practice). Group 2 (Epidural Needle Administration ) participants will receive the 10 mL epidural loading dose in 5 mL increments via the epidural needle prior to catheter placement (experimental group). Various parameters will be measured in the time after drug administration to evaluate blood pressure, heart rate, and fetal heart rate. Following delivery, the total anesthetic dose, total number of doses demanded, total number and dosage of rescue doses, and overall patient satisfaction will be recorded.
研究者
Goran Ristev
Assistant Clinical Professor of Anesthesiology
Ohio State University
入排标准
入选标准
- •subjects who have volunteered and consented to participation in the study upon admission to labor and delivery
- •parturients in active labor requesting epidural analgesia
- •uncomplicated pregnancy with a reassuring fetal heart tracing
- •age≥18 years
排除标准
- •contraindication to epidural anesthesia
- •inability to read, comprehend, and sign the informed consent form
- •fetal intrauterine growth retardation (IUGR)
- •non-reassuring fetal heart tracing
- •cervical dilation greater than 7cm
- •intra-uterine fetal demise
- •any spinal pathology or neurologic disease
- •history of chronic pain
- •incarcerated patients
- •any patient enrolled in the study in whom there is evidence of dural puncture during epidural technique (\>3 attempts, presence of CSF).
结局指标
主要结局
Mean VAS pain score
时间窗: 20 minutes
Mean VAS pain score will be determined 20 minutes following epidural loading, including assessments at 5, 10, 15, and 20 minutes.
次要结局
- Maternal Heart Rate(Baseline and 20 minutes)
- Rescue Bolus Count(During Labor)
- Intravascular catheter placement(During labor)
- Analgesic level(10, 15, and 20 minutes)
- Maternal Blood Pressure(Baseline and 20 minutes)
- Fetal Heart Rate(Baseline and 20 minutes)
- Analgesia Satisfaction(During labor)
- Total anesthetic dose required(During Labor)