The Role of Lidocaine Spray in Reducing Pain During Intrauterine Device Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain component
研究概览
简要总结
Investigators aimed to investigate the effectiveness of the use of local lidocaine spray application to make routine intrauterine intrauterine device application more painless.
详细描述
As a standard, no anaesthesia is applied to the patient during intrauterine device application in outpatient clinic conditions. Patients can usually tolerate the procedure even if there is minimal pain and discomfort. In patients with low pain tolerance, the procedure can be terminated before the application can be performed and the application can be repeated under local or general anaesthesia. Local anaesthetic sprays are routinely and comfortably used in episiotomy repair, upper gastrointestinal tract endoscopy and intraoral procedures. In our study, investigators aimed to demonstrate the efficacy of local spray anaesthesia without side effects for the relief of pain that occurs in some patients during intrauterine device application by comparing it with placebo.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
off labeled and hidden bottle usage during spray apply
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-45 years old patient who comes to have an intrauterine device inserted voluntarily
- •The patient who gave consent to participate in the study
排除标准
- •Patients who cannot have an intrauterine device because of fibroids or cervical stenosis
- •Patient who did not want to participate in the study
研究组 & 干预措施
Placebo group
This group received saline spray during intrauterine device application.
干预措施: Lidocain spray (Drug)
Active group
This group received lidocaine spray during intrauterine device application.
干预措施: Lidocain spray (Drug)
结局指标
主要结局
Pain component
时间窗: 1 hour
Reduction of the pain felt during application of the intrauterine device
次要结局
未报告次要终点
研究者
Ergul Demircivi Bor
assistant professor
Istanbul Medeniyet University
