Lidocaine Spray Compared With Submucosal Injection in Reducing Pain During Loop Electrosurgical Excision Procedure: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Visual analog pain scores immediately after the excision
研究概览
简要总结
Loop Electrosurgical Excision Procedure (LEEP) is a widely used minor surgical procedure for diagnosis and treatment of cervical intraepithelial neoplasia. During the procedure, several methods have been proposed to reducing pain including submucosal block, paracervical block, and oral analgesics. Submucosal (underneath the lining of the cervix) injection of lidocaine appeared to be the most common methods used. However, from the investigators experience, there is significant pain associated with the injection itself.
Lidocaine spray is an effective measure for pain control during minor gastrointestinal and otolaryngological procedures. It is simple without pain related to application.
An objective of this study is to examine effectiveness of lidocaine spray versus lidocaine submucosal injection by comparing pain scores at various stages of the LEEP procedure.
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
- Single (Participant)
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
- •Any degrees of cervical dysplasia detected from cervical cytology or histology
- •Need to have loop electrosurgical excision procedure (LEEP) for diagnosis and/or treatment
排除标准
- •Allergy to lidocaine
- •Pregnancy
- •Previous history of cervical operation including conization, LEEP, laser therapy and cryotherapy
- •Cardiac arrhythmia
- •Neural disease with impaired sensation
- •Lower urinary tract cancer
- •Coagulation defect
- •Drug dependence
- •Lower genital tract infection
- •Obvious invasive disease of the cervix
结局指标
主要结局
Visual analog pain scores immediately after the excision
时间窗: Immediately after the excision
次要结局
- Visual analog pain scores at the time of anesthetic application(At the time of anesthetic application)
- Visual analog pain scores at 30 minutes after the procedure(At 30 minutes after the procedure)
研究者
Kittipat Charoenkwan, M.D.
Associate Professor
Chiang Mai University