NCT00564785已完成4 期
A Randomized, Double-Blind, Controlled Trial of the Synera™ vs. Lidocaine for Epidural Needle Insertion in Laboring Women
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
- 33
- 试验地点
- 1
- 主要终点
- Subject VRS (0 - 11) with epidural needle insertion
研究概览
简要总结
We hypothesized that the analgesic effect of Synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.
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
- 否
入选标准
- •older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural
排除标准
- •hypersensitivity to any study medications
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo patch (Other)
Synera(TM)
Experimental
干预措施: Synera(TM) (Drug)
结局指标
主要结局
Subject VRS (0 - 11) with epidural needle insertion
时间窗: 1 hour
次要结局
- Anesthesia provider perceived VRS(1 hour)
- Need for deep infiltration with local anesthesia(1 hour)
研究者
研究点 (1)
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