Prospective, Controlled, Randomized, Blinded, Single-center Study of the Clinical Efficacy and Outcomes of a Multiport Versus Uniport Flexible Catheter for Epidural Analgesia During Labor and Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Analgesic success rate
研究概览
简要总结
The purpose of this study is to determine whether multiple ports improve the analgesic efficacy of flexible catheters used for the provision of epidural analgesia during the entire continuum of labor and delivery
详细描述
Multiport catheters, when compared to uniport catheters, have been associated with better analgesic quality during labor epidural analgesia because the presence of more than one port may enhance the distribution of epidural medication
Flexible catheters, when compared to rigid catheters, have been associated with better analgesic quality during labor epidural analgesia because greater flexibility may minimize catheter deviation in the epidural space, facilitate more optimal catheter placement in the epidural space, and result in better distribution of epidural medication
It is unknown whether multiple ports, which promote better distribution of epidural medication, provide added analgesic benefit to flexible catheters, which also facilitate better distribution of epidural medication, when used for the provision of epidural analgesia during labor and delivery
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Classification I-III parturients
- •Mixed parity
- •Estimated gestational age of at least 37 weeks
- •Singleton gestation
- •Cephalic presentation
- •Spontaneous or induced labor
排除标准
- •Body mass index (BMI) > 45 kg/m2
- •Prior cesarean section
- •Multiple gestation
- •Fetal abnormality
- •Use of chronic analgesic medication
- •Local anesthetic allergy
- •Coagulopathy or anticoagulation
- •Infection at epidural insertion site
- •Spinal deformity other than mild scoliosis
- •Uncontrolled/uncompensated/uncorrected cerebral, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrinologic, metabolic, or hematologic condition
结局指标
主要结局
Analgesic success rate
时间窗: 30 minutes following the initiation of labor epidural analgesia
Complete analgesia is defined as the complete relief of pain during contractions following the administration of the above epidural medication without requiring further epidural medication/intervention.
Analgesic success rate
时间窗: 30 minutes following the initiation of labor epidural analgesia
Complete analgesia is defined as the complete relief of pain during contractions following the administration of the above epidural medication without requiring further epidural medication/intervention.
次要结局
- Anesthetic success rate(10 minutes following the initiation of epidural anesthesia for cesarean delivery)
- Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery(24 hours following delivery)
- Number of Clinician interventions during the first stage of labor(The duration of first stage of labor, an expected average of 6 hours and 30 minutes)
- Maternal satisfaction with the overall quality of analgesia/anesthesia during labor and delivery(24 hours following delivery)
- Anesthetic success rate(10 minutes following the initiation of epidural anesthesia for cesarean delivery)