Transdermal Lidocaine for Pain Control During Hysterosalpingography: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mean pain score during the procedure
研究概览
简要总结
the study aims to investigate the effectiveness of Transdermal lidocaine patch for Pain Control During Hysterosalpingography
详细描述
hysterosalpingography can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the cannula; and injection of the dye
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind randomized trial
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
- •any patient came for Hysterosalpingography
排除标准
- •any patient has contraindication to Hysterosalpingography
研究组 & 干预措施
lidocaine patch
5% lidocaine patch applied at 3 hours before the procedure
干预措施: lidocaine patch (Drug)
Sham patch
Sham patch containing no study medication applied 3 hours before the procedure
干预措施: Sham patch (Drug)
结局指标
主要结局
Mean pain score during the procedure
时间窗: 10 minutes
Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores
次要结局
未报告次要终点
研究者
hany farouk
A Professor
Aswan University Hospital