Parturient Satisfaction With Epidural Analgesia During Parturient Controlled Pump
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Parturient satisfaction with analgesia
研究概览
简要总结
Those prospective parturients that express that they may want an epidural labour analgesia for their delivery will be informed about the possibility to choose between a pump driven epidural or midwife administered intermittent boluses.
详细描述
The purpose is to compare parturient and midwife satisfaction with the epidural labour analgesia when epidural analgesia is maintained by an epidural bolus pump (automated mandatory boluses with patient controlled boluses without background infusion) or midwife administered on-demand boluses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Admitted to the delivery hospital with the prospect of vaginal delivery
- •On admission when questioned about planned analgesia expresses that may want an epidural analgesia for the planned vaginal delivery
- •After reading the study prochure signs the participation (consent) form
- •Sufficient command of Finnish or Swedish to facilitate interview
排除标准
- •Contraindications for epidural analgesia
- •Planned cesarean delivery
- •Age under 18 years
研究组 & 干预措施
Midwife administered boluses
The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued on-demand by similar boluses until delivery
干预措施: Ropivacaine Hydrocloride (Drug)
Midwife administered boluses
The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued on-demand by similar boluses until delivery
干预措施: Fentanyl Citrate (Drug)
Automated and parturient controlled epidural boluses
The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued by automated boluses of the same solution (6ml every 40 minutes) with possibility for the parturient to administer 6 ml extra doses with a 20 minute lock-out. Maximum hourly dose 20 ml.
干预措施: Ropivacaine Hydrocloride (Drug)
Automated and parturient controlled epidural boluses
The epidural analgesia is initiated by a manual bolus of the epidural solution (ropivacaine 1 mg/ml fentanyl 2.5 mug/ml) 10 + 10 ml and then continued by automated boluses of the same solution (6ml every 40 minutes) with possibility for the parturient to administer 6 ml extra doses with a 20 minute lock-out. Maximum hourly dose 20 ml.
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
Parturient satisfaction with analgesia
时间窗: During use of labour analgesia (up to 6 hours)
Visual analog scale 0-100 mm (0=dissatisfied; 100=maximum satisfaction)
次要结局
- Midwife satisfaction with epidural labour analgesia(During use of labour analgesia (up to 6 hours))
- Support person's satisfaction with epidural labour analgesia(During use of labour analgesia (up to 6 hours))
研究者
Antti Vaananen
Anesthesiologist MD PhD
Helsinki University Central Hospital