Epidural Analgesia During Labour. Impact of Clonidine Addition to Levobupivacaine and Sufentanil
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
研究概览
简要总结
Addition of clonidine to an epidural mixture of local anaesthetic and morphine improves analgesia and reduces the frequency of motor blockade during epidural analgesia. several side effects are possible mostly somnolence and hypotension. Association of continuous clonidine infusion with low concentrations of levobupivacaïne and sufentanil was not studied during labour. The objective of this study is to compare the effectiveness and the side effects of a PCEA with levobupivacaïne 0,0625 % and sufentanil 0.25 microg.ml-1, without addition of clonidine, and with addition of clonidine at a concentrations of 2 microg.ml-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients of ASA class I or II
- •Variable parity
- •Aged of 18 years or more
- •With a normal pregnancy
- •Cervical dilation between 3 and 8 cm)
- •Wishing an epidural analgesia
- •Normal childbirth
- •Giving their written assent
- •Affiliated with a social security system
- •Must have had an anaesthesia consultation more than 48 hours before inclusion.
排除标准
- •Request of the patient
- •Failure of epidural analgesia
- •Childbirth in the 90 minutes following the induction of analgesia
- •Realization of a Caesarean section
结局指标
主要结局
Score of quality at the time of the childbirth based on a 4-point scale : motor blockade - no sensation - nonpainful sensation - pain.
次要结局
- Motor blockade quantification by a score of modified Bromage specific way.
- Labor analgesia.
- Circulatory parameters(arterial pressure and heart rate will be noticed at 5 - 10 - 15 - 20 - 30 - 60 minutes and every hour until childbirth).