EUCTR2015-005247-14-BE进行中（未招募）1 期
Effect of levobupivacaine infiltration versus placebo on perineal postpartum pain in episiotomy of primiparous, after instrumental delivery: randomized double blind clinical trial.
Centre Hospitalier Universitaire Brugmann0 个研究点目标入组 330 人开始时间: 2016年6月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Primiparous
- •-Vaginal delivery with instrumentation (Suzor forceps, vacuum extraction, Thierry spatulas), with episiotomy
- •-Fœtus In cephalic position
- •-Single pregnancy
- •-Patient at least 18 years old
- •-Term superior or equal to 37 weeks of amenorrhea
- •-Patient under epidural analgesia
- •-Patient affiliated to a social security scheme
- •-Patient having a good understanding of French
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 330
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Ineffective epidural analgesia, defined as the need of an additional local anesthesia for episiotomy repair
- •- Perineal tear of 3rd and 4rd grade, according to the Anglo-saxon classification
- •- Contra-indication to levobupivacaine, paracetamol, ketoprofen
- •- Protocol participation refusal
- •- Postpartum hemorrhage requiring arterial embolization, reoperation (evacuation of a vaginal thrombus, vessel ligation, hysterectomy by laparotomy) or balloon Bakri® placement.
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