Pain Management With Lidocaine-prilocaine Spray During Diagnostic Office Hysteroscopy in Postmenopausal Women: a Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 106
- 主要终点
- Intensity of pain
研究概览
简要总结
To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists
详细描述
To assess the effectiveness of lidocaine-prilocaine spray versus placebo in minimizing the pain experienced by postmenopausal patients during diagnostic office hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopists
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
排除标准
- •Nulliparous patients patients with cervical pathology retroverted uterus (detected by transvaginal ultrasound) previous cervical surgery patients with severe vaginal bleeding allergy or contraindications to lidocaine-prilocaine spray
研究组 & 干预措施
lidocaine prilocaine
干预措施: Lidocaine-Prilocaine Topical (Drug)
placebo
干预措施: Saline spray (Drug)
结局指标
主要结局
Intensity of pain
时间窗: 5 minutes
Pain intensity will be assessed by visual analogue scale during the procedure.visual analogue scale ranging from 0 to 10
次要结局
- Intensity of pain(20 minutes)
- ease of insertion(5 MINUTES)
研究者
Ahmed Samy aly ashour
professor
Cairo University