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临床试验/NCT07155785
NCT07155785已完成不适用

The Role of Lidocaine Spray in Reducing Pain During Intrauterine Device Application

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年7月1日最近更新:
干预措施
相关药物

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

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

Placebo Comparator

This group received saline spray during intrauterine device application.

干预措施: Lidocain spray (Drug)

Active group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ergul Demircivi Bor

assistant professor

Istanbul Medeniyet University

研究点 (1)

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