NCT02883179已完成4 期
Topical Lidocaine-prilocaine Cream Versus Lidocaine Infiltration for Pain Relief During Repair of Postpartum Perineal Tears: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Mean pain score during suture of perineal tears
研究概览
简要总结
The aim of our study is to compare the analgesic effect of topical application of lidocaine-prilocaine cream and lidocaine infiltration during repair of postpartum perineal tears.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age > 37 weeks
- •Uncomplicated pregnancy
- •Single vertex fetus
- •Normal vaginal delivery
- •Women who will accept to participate in the study
排除标准
- •Women received epidural analgesia
- •Women required episiotomy
- •Women with intact perineum
- •Operative vaginal delivery
- •Allergy to the used drugs
研究组 & 干预措施
lidocaine injection
Active Comparator
5 mL of 2% lidocaine anhydrous solution (Depocaine) will be injected slowly along the lines of the edges of the perineal tears after delivery, with frequent aspirations to avoid intravascular injection.
干预措施: lidocaine injection (Drug)
lidocaine-prilocaine cream
Experimental
5-g dose of Lidocaine-prilocaine cream will be applied to the intact tissue around each tear for 5 minutes before suturing
干预措施: lidocaine-prilocaine cream (Drug)
结局指标
主要结局
Mean pain score during suture of perineal tears
时间窗: 30 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
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