A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Number of clinician administered rescue boluses
研究概览
简要总结
Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous,
- •English speaking
- •18-45 years
- •single gestation ≥ 37 weeks
- •vertex presentation
- •American Society of Anesthesiologists (ASA) Physical Status II (mild and controlled systemic disease and/or pregnancy)
- •requesting an epidural for labour analgesia
- •cervical dilation ≤ 7 cm at the time of initiation of epidural analgesia.
排除标准
- •Preeclampsia or HELLP syndrome
- •maternal cardiac disease
- •severe or uncontrolled maternal systemic disease
- •contraindication to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
- •abnormal spinal anatomy (i.e. severe scoliosis, spina bifida, spinal instrumentation)
- •chronic analgesic use
- •a physical or psychiatric condition which may impair cooperation
- •known fetal anomalies/intrauterine fetal demise
- •height < 5'0"
- •Body Mass Index > 45 kg/m2
结局指标
主要结局
Number of clinician administered rescue boluses
时间窗: Start of labour epidural to delivery time
Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump
Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered
时间窗: Start of labour epidural to delivery time
Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery
Maternal satisfaction score
时间窗: 24 hours following delivery
quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied
次要结局
未报告次要终点
研究者
Allana
Principle Investigator
IWK Health Centre