NCT02905695已完成4 期
Contribution of the Local Infiltration of Chirocaine® in the Management of the Post-partum Perineal Pain After Episiotomy or First-degree Tear
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Post-partum perineal pain measured by a numerical rating scale
研究概览
简要总结
The aim of this placebo-controlled clinical trial is to assess the effectiveness of the local infiltration of the analgesic Chirocaïne® on perineal pain after episiotomy or first-degree tear. The pain intensity is measured in immediate postpartum period by using a numerical rating scale (NRS) at the following times: H2, H4, H8, H12, H24, H36, H48 during rest, defecation and during activities. The safety of Chirocaïne® and the patient satisfaction are also evaluated at each time.
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
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Patients aged 18-45 years
- •Single pregnancy.
- •Vaginal normal birth in cephalic presentation or assisted vaginal delivery by vacuum extractor.
- •Patients having a mediolateral episiotomy or a first-degree perineal tear, epidural analgesia.
- •Patients affiliated to a national insurance scheme
- •Patients who have given their written consent
排除标准
- •Patient not speaking, reading, writing French.
- •Multiple pregnancy.
- •Breech delivery or instrumental delivery by forceps or spatula.
- •Intact perineum.
- •No epidural analgesia.
- •Patient who represent contraindication to local anesthetics, severe arterial hypotension.
- •Previous tear requiring sutures.
研究组 & 干预措施
Group A
Experimental
Chirocaine
干预措施: Chirocaine (Drug)
Group B
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Post-partum perineal pain measured by a numerical rating scale
时间窗: 8 hours post partum
次要结局
未报告次要终点
研究者
研究点 (1)
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