Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain intensity will be assessed by visual analogue scale
研究概览
简要总结
To compare the effectiveness of Transdermal Lidocaine for Pain Control During Diagnostic Office Hysteroscopy
详细描述
hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, fibroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. Cervical ripening is made possible by the use of medication through different routes.
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 blinded randomized controlled trial
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with an indication for office hysteroscopy
排除标准
- •patient refuse to participant
- •contraindication for lidocaine patch
研究组 & 干预措施
lidocaine patch
5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
干预措施: lidocaine patch (Drug)
Sham patch
Sham patch applied at 6 hours before the scheduled office hysteroscopy.
干预措施: Sham patch (Drug)
结局指标
主要结局
Pain intensity will be assessed by visual analogue scale
时间窗: 10 minutes
Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure. Visual analogue scale ranging from 0 to 10
次要结局
- Operative time(15 minutes)
研究者
hany farouk
A Professor
Aswan University Hospital