Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Analgesia at 20 minutes
研究概览
简要总结
A total of 60 parturients undergoing induction of labour will be consented to participate in the study where they will be randomized to receive either spinal fentanyl (20 µg) or epidural analgesia (fentanyl 100µg and lidocaine 80 mg).
They will be monitored for the development of analgesia for a duration of 30 minutes.
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)
盲法说明
The parturient and the midwife as well as the researcher doing the interview for analgesia will be masked. The anesthesiologist performing either spinal fentanyl administration or epidural analgesia will not be masked
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signs a consent form to participate voluntarily into the trial
- •Induced labor
- •singleton pregnancy
- •primiparous
- •BMI 20-40 at the time of delivery
- •No history of allergy for lidocaine or fentanyl
- •sufficient command of Finnish language to understand the consent form and interview
- •Cervical dilatation at maximum 4 cm at the time of intervention
排除标准
- •Any contraindication for spinal or epidural analgesia
- •Allergy for lidocaine or fentanyl
- •The patient has received any opioid medication within 90 minutes prior to intervention
研究组 & 干预措施
Spinal fentanyl
Using a combined spinal epidural technique a single dose of 20 µg of fentanyl diluted into 2 ml with NaCl 0.9 % will be injected into the CSF at lower lumbar interspace. An epidural catheter is left in place for subsequent analgesic doses.
干预措施: Fentanyl Citrate (Drug)
Epidural lidocaine and fentanyl
Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given. The epidural catheter is left in place for subsequent analgesic doses.
干预措施: Lidocaine 1% Injectable Solution (Drug)
Epidural lidocaine and fentanyl
Using a catheter in the epidural space in the lower lumbar interspace a single dose of lidocaine (80 mg) and fentanyl (100 µg) is given. The epidural catheter is left in place for subsequent analgesic doses.
干预措施: Fentanyl Citrate (Drug)
结局指标
主要结局
Analgesia at 20 minutes
时间窗: 20 minutes
Reduction of visual analog scale (VAS) pain during contraction from pre-intervention value. 0 mm means no pain while 100 mm means worst possible pain.
次要结局
- Pruritus(0-30 minutes)
- Changes in the cardiotocography (fetal heart rate) within 30 minutes after the intervention(0-30 minutes)
- Time until pain returns to 60 mm VAS(30-180 minutes)
- Ambulation during the analgesia provided by the intervention(30-180 minutes)
- Use of oxytocin during the analgesia study period(30 min)
- Cervical dilatation rate cm/h during the analgesia intervention(0-180 min)
- SAtisfaction of the parturient with the analgesia provided by the intervention(at 30 minutes)
研究者
Antti Vaananen
Anesthesiologist
Women's Hospital HUS