Effect of Programmed Intermittent Epidural Bolus Delivery Rate on the Quality of Labour Analgesia: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Breakthrough pain
研究概览
简要总结
Comparison of three programmed intermittent epidural bolus (PIEB) pump settings for maintenance of labour analgesia.
详细描述
The optimal PIEB and patient controlled epidural administered (PCEA) bolus settings are still unknown. Therefore, in this study, the investigators aim to compare analgesia outcomes both high and low PIEB flow rate settings.
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, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton, vertex presentations at term (37-42 weeks gestational age)
- •</= 5cm cervical dilation at the time of epidural anesthesia request
- •ASA 2-3 patients aged 19 or over who are able to provide informed consent
排除标准
- •Contraindications to neuraxial analgesia or risk factors likely to affect placement or function of the epidural
- •History of hypersensitivity or idiosyncratic reaction to local anesthetics or opioids
- •Current or historical evidence of any significant medical conditions
- •Clinical settings in which continuous epidural infusion may be preferable
- •Risk factors significantly increasing the need for Cesarean delivery
- •Anticipated fetal abnormalities
研究组 & 干预措施
Group A
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settings:
PIEB flow rate = high; interval = 60 min
干预措施: Bupivacaine 0.08% - fentanyl 2mcg (Drug)
Group B
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = high; interval = 45 min
干预措施: Bupivacaine 0.08% - fentanyl 2mcg (Drug)
Group C
Bupivacaine 0.08% - fentanyl 2mcg on the following pump settin PIEB flow rate = low; interval = 45 min
干预措施: Bupivacaine 0.08% - fentanyl 2mcg (Drug)
结局指标
主要结局
Breakthrough pain
时间窗: Duration of labor with epidural
Proportion of patients in each group who required a provider administered supplemental bolus for breakthrough pain
次要结局
未报告次要终点
研究者
Anthony Chau
Clinical Assistant Professor
University of British Columbia