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临床试验/NCT03382743
NCT03382743Unknown2 期

Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy - a Randomized Control Trial.

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
200
试验地点
2
主要终点
Procedure time

研究概览

简要总结

lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

详细描述

5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

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
Single (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

排除标准

  • Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.

研究组 & 干预措施

Group A (Lidocaine group)

Active Comparator

5 sprays of endocervical Lidocaine 10% spray ( AstraZeneca, bedforshire) are used 3 minutes before office hysteroscopy

干预措施: Endocervical Lidocaine spray (Drug)

结局指标

主要结局

Procedure time

时间窗: immediately after the process

from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity

Pain sensation

时间窗: The VAS will be applied immediately after the procedure ended

The level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS)

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

sarah mohamed hassan

principal investigator ,lecturer of obstetrics and gynecology

Kasr El Aini Hospital

研究点 (2)

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