Effects of a Systematic Addition of Clonidine in the Local Anaesthetic and Opiate Solution for Epidural Patient Controlled Analgesia in Labour (Levobupivacaine 0.568 mg.mLl-1 + Sufentanil 0.45 µg.mL-1)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of required additional epidural boluses, either self-administered or medically given as a rescue
研究概览
简要总结
In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation < 5 cm, epidural analgesia will be given with an initial volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual injections to achieve analgesia, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic solution will be levobupivacaine presented in 100-mL bags from the market (0.0625%), in which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design.
详细描述
We recently compared the analgesic effects of the two presentations of levobupivacaine available on the French market, (0.625 and 1.25 mg.mL-1 in pre-filled bags), both with sufentanil. It appeared that the high concentration was more powerful, however leading in some cases to give doses of levobupivacaine superior to the label's recommendations. This indicates to use the low concentration, with a risk of a poorer efficacy. Our aim is to show that efficacy can be restored with a systematic addition of clonidine, which has documented analgesic properties when administered perispinally.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturient is 18 years old
- •ASA physical status 1 or 2
- •Primiparity
- •Singleton
- •Gestational age is 36 weeks
- •Spontaneous labour with cervical dilatation of 5 cm
排除标准
- 未提供
研究组 & 干预措施
no clonidine
干预措施: Clonidine (Drug)
clonidine
干预措施: Clonidine (Drug)
结局指标
主要结局
Number of required additional epidural boluses, either self-administered or medically given as a rescue
时间窗: during labour
次要结局
- Spontaneous pain during labour (on VAS)(during labour)
- Pain at delivery(at delivery)
- Pain at post-delivery sutures(at post-delivery sutures)
- Motor block(during labour)
- Duration of labour(during labour)
- Obstetrical events (caesarean section, instrumental delivery)(after delivery)