Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
研究概览
简要总结
In this study the analgesic effect of two different opioids (fentanyl and sufentanil) will be compared when given either intrathecally or epidurally in primiparous parturients during early phase of the labour.
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
- •Primiparous parturients
- •In early phase of labour (cervical dilatation at or under 5 cm)
- •No prior opioids by any route of administration within past 120 min
- •Pain at or over 80 mm on 0-100 mm visual analog scale during contraction
排除标准
- •Allergy for any of the medications used
- •Contraindications for epidural/spinal analgesia
- •BMI at the time of delivery under 20 or over 35 kg/m2
研究组 & 干预措施
Spinal fentanyl
20 micrograms of intrathecally administered fentanyl in single dose. Total volume of intrathecal injection 2 ml.
干预措施: Spinal analgesia for labour pain (Drug)
Epidural fentanyl
100 micrograms of epidurally administered fentanyl in a single dose. Total volume of epidural injection 7 ml.
干预措施: Epidural analgesia for labour pain (Drug)
Spinal sufentanil
5 micrograms of intrathecally administered sufentanil in a single dose. Total volume of intrathecal injection 2 ml.
干预措施: Spinal analgesia for labour pain (Drug)
Epidural sufentanil
20 micrograms of epidurally administered sufentanil in a single dose. Total volume of epidural injection 7 ml.
干预措施: Epidural analgesia for labour pain (Drug)
结局指标
主要结局
Change of Maximum Pain During Contraction at 20 Minutes After the Study Drug Delivery
时间窗: 20 minutes
All parturients are to have a pain visual analog scale (VAS - on a 0-100 mm scale) at 80mm or higher before the initial study drug delivery. On this scale 0 mm presents a totally pain free condition while 100 mm presents the worst imaginable pain. The change of maximum pain in millimeters on the VAS scale during the 20 minutes following the study drug delivery will be recorded.
次要结局
- The Duration of Labour Analgesia After the Single Dose of Epidural or Intrathecal Opioid(The data below report an average duration of time that is typically less than three hours)
研究者
Jouni Ahonen
MD, Ph.D.
Helsinki University Central Hospital