Programmed Intermittent Epidural Bolus Versus Continuous Infusion When Added to Patient-controlled Epidural Analgesia on Bupivacaine Consumption in Labour Analgesia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Dose of bupivacaine in milligrams per hour
研究概览
简要总结
This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.
详细描述
Patients are randomised to receive either a programmed bolus of 6ml each 45 minutes or a continuous infusion of 8ml/h. In each group, they have the possibility to add a PCEA bolus of 6ml every 20min as needed.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant nulliparous or multiparous woman in labour
- •Age ≥18 years
- •Obtained consent for epidural analgesia
- •ASA classification I-II-III
- •Early labour (cervical dilation ≤6cm)
排除标准
- •Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus)
- •Prematurity (<36 weeks of gestation)
- •Multiple gestation
- •Fentanyl allergy or hypersensitivity
- •Patient unable to understand the PCEA
- •Fetal breech position
- •Maternal cardiac pathology and contraindication to Valsalva manoeuvre
- •Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus
- •Intrathecal catheter or intravascular catheter
- •Accidental dural puncture
- •Patient refusal
- •Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia
结局指标
主要结局
Dose of bupivacaine in milligrams per hour
时间窗: 1 day
Total dose of bupivacaine in milligrams divided by the total duration of the epidural in hours
次要结局
- Time lapse before the first PCEA request after the epidural connection(1 day)
- First stage(1 day)
- Evaluation of pain(1 day)
- Assisted vaginal delivery(1 day)
- PCEA boluses requested(1 day)
- Second stage(1 day)
- Cesarean section(1 day)
- Anesthesiologist manual bolus(1 day)
- PCEA boluses received(1 day)
- Patient satisfaction(1 day)
- Motor blockade(1 day)
研究者
Geneviève Rivard
Principal investigator
Université de Sherbrooke