Relieving Outpatient Hysteroscopy-associated Pain: What is the Most Effective Method?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Intensification of pain in Numeric Rating Scale: 0-10
研究概览
简要总结
Hysteroscopy is a reference diagnostic and therapeutic procedure in intrauterine pathologies, increasingly performed without general anesthesia. Pain is the most common reason for discontinuation of outpatient hysteroscopy (OH). There is no consensus on pain alleviation during OH. The aim was to compare the effectiveness of pain relief options during OH.
详细描述
A prospective randomized trial (consent no.1072.6120.228.2021) includes women subjected to OH due to focal uterine lesion, abnormal uterine bleeding, or infertility. Women are randomly assigned to 3 arms - A: NSAID (ketoprofen 100 mg intravenously), B: A+infiltration anesthesia (20 ml 1% lidocaine), C: A+paracervical block (20 ml 1% lidocaine). Karl Storz 5.0 mm Bettocchi® operative sheath with 2.9 mm 30 degree telescope and 5 Fr working channel was used. Intensity of pain in numeric rating scale (NRS), intensity of cervical bleeding, frequency of vaso-vagal reaction, and frequency of abandoning/ limiting the procedure were compared.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age over 18
- •indications for hysteroscopy: focal uterine lesion, abnormal uterine bleeding, or infertility
排除标准
- •allergies to medications
- •refusal to consent to the procedure or participation in the study
结局指标
主要结局
Intensification of pain in Numeric Rating Scale: 0-10
时间窗: up to 6 months
Measurement and comparison of the intensity of pain in numeric rating scale (NRS) during and after the procedure in 3 study arms
次要结局
- Intensity of cervical bleeding on the assumed scale: 0-3(up to 6 months)
- Occurrence of vaso-vagal reaction during the procedure(up to 6 months)
- Occurrence of abandoning/ limiting the procedure(up to 6 months)
研究者
Iwona Magdalena Gawron
Ph.D., Principal Investigator
Jagiellonian University