Randomized Controlled Trial of Local Lidocaine Gel and Intrauterine Lidocaine Infusion for Pain Relief During Saline Infusion Sonohysterography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain level as assessed by the visual analog scale
研究概览
简要总结
This is a randomized, double-blinded, double placebo-controlled trial. Patients undergoing saline infusion sonohysterography (SIS) will be recruited and randomized into three groups to receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline; (b) 3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY jelly on the cervix and 5mL of intrauterine normal saline prior to SIS. Pain levels will be recorded to evaluate the efficacy of local lidocaine gel and intrauterine lidocaine infusion in reducing pain during the SIS.
详细描述
Trial objectives and purpose:
To evaluate the efficacy of local lidocaine gel and intrauterine lidocaine infusion in reducing pain during saline infusion sonohysterography (SIS).
Trial design:
This is a randomized, double-blinded, double placebo-controlled trial. Patients undergoing SIS will be recruited and randomized into three groups to receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline; (b) 3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY jelly on the cervix and 5mL of intrauterine normal saline prior to SIS.
Randomization Before the procedure, each patient will be randomized into three groups with a predetermined computer-generated randomization code prepared by a research nurse to receive (a) 3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline; (b) 3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine or (c) 3ml of KY jelly on the cervix and 5mL of intrauterine normal saline prior to SIS. Demographic data will be collected from all patients.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years or older being scheduled for saline infusion sonohysterography
排除标准
- •History of cervical stenosis
- •Known allergy to lidocaine
- •Pregnancy
- •Acute cervicitis
- •Profuse vaginal bleeding
- •Consumption of pain killers on the day of procedure
研究组 & 干预措施
Lidocaine gel group
3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline
干预措施: Lidocaine gel (Drug)
Lidocaine gel group
3ml of 2% lidocaine gel on the cervix and 5ml of intrauterine normal saline
干预措施: Intrauterine normal saline (Drug)
Intrauterine lidocaine group
3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine
干预措施: Intrauterine lidocaine (Drug)
Intrauterine lidocaine group
3ml of KY jelly on the cervix and 5ml of 2% intrauterine lidocaine
干预措施: KY jelly (Drug)
Placebo group
3ml of KY jelly on the cervix and 5mL of intrauterine normal saline
干预措施: KY jelly (Drug)
Placebo group
3ml of KY jelly on the cervix and 5mL of intrauterine normal saline
干预措施: Intrauterine normal saline (Drug)
结局指标
主要结局
Pain level as assessed by the visual analog scale
时间窗: Up to 20 minutues after the procedure
Pain level during and after the saline infusion sonohysterography procedure as assessed by the visual analog scale
次要结局
- Distress as evaluated by the physician with a 3-point observer scale(Just after the procedure)
- Analgesics(1 hour)
- Side effects(1 hour)
研究者
Dr. YUNG Shuk Fei Sofie
Clinical Assistant Professor
The University of Hong Kong