Epidural Analgesia During Labour Randomized Clinical Trial Comparing Patient Controlled Epidural Analgesia Versus Patient Intermittent Epidural Boluses With Levobupivacaine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- VAS
研究概览
简要总结
Randomized single blind trial based on comparing the way the local anesthetic is dosificated during labour. The pain control is evaluated and compared with both dosage techniques (PCEA vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and secondary effects of local anesthetic.
详细描述
There is a protocol where every healthy primiparous women have the chance to join the study after the explanation and the informed consent is signed. There are blind envelopes with the two kinds of treatment and the investigator only has to follow the protocol.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •20- 40 years-old women
- •Primiparous women
- •Dilatation 3- 7 cm
- •No risk illnesses for epidural block
- •No risk pregnancy
- •Signed informed consent
排除标准
- •Illnesses which are a risk for pregnancy
- •Multiparous women
- •Contraindicated diseases for epidural block
- •Women who can not understand the procedure
- •Women who do not want to sign the informed consent
- •Patients with drug´s allergy
结局指标
主要结局
VAS
时间窗: 4 times after epidural block: previous, 1 hour after, 2 hours after, 15 minutes after delivery
Change from baseline in Visual Analog Scale
次要结局
- Bromage Scale(15 minutes after Epidural Block and 1 hour after epidural block)
- Apgar at birth(5 minutes after birth)
- fetal pH at birth(0 minutes after delivery)
- Satisfaction (Likert Scale)(1 hour after delivery)
- Expulsive time(From 10 cm of dilatation until delivery)
- Total Dosis of Levobupivacaine(0 minutes after delivery)
- Labour Outcome(Delivery)
研究者
MARIA BELEN RODRIGUEZ-CAMPOO
PhD title in Medicine and Surgery
Hospital del Rio Hortega