NCT02710305已完成2 期
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide With Cervical Lidocaine Cream in Reducing Pain During Hysterosalpingography
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean pain score during HSG
研究概览
简要总结
hysterosalpingography is a diagnosis procedure in the evaluation of infertile women and considered to be the traditional and the gold standard in the assessment of the patency of the fallopian tubes. The major disadvantage of hysterosalpingography is pain. In a study reported the patients complained of moderate to severe pain during the procedure. It is reported that some patients undergoing hysterosalpingography was more stressful and anxiety and effect on pain scores.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The infertile women who indicated for HSG
排除标准
- •contraindications to Hyoscine or lidocaine
- •known sensitivity to contrast media
- •abnormal uterine bleeding
- •genital tract infection
- •suspected pregnancy
研究组 & 干预措施
Group A
Active Comparator
oral hyoscine butyl bromide tablets plus lidocaine cream
干预措施: oral hyoscine butyl bromide tablets plus lidocaine cream (Drug)
Group B
Placebo Comparator
oral placebo tablets plus placebo cream
干预措施: oral placebo tablets plus placebo cream (Drug)
结局指标
主要结局
Mean pain score during HSG
时间窗: intraoperative
次要结局
- rate of side effects(30 minutes)
- Mean pain score after HSG(30 minutes)
研究者
研究点 (1)
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