2024-514117-35-00招募中4 期
Evaluation of the value of perianal infiltration during thermodestruction of hemorrhoidal disease by Radiofrequency (RAFAELO® procedure)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Visual analogue scale (VAS) at H6 post-op (6 hours after the start of the procedure). The H6 criterion was retained, since the duration of efficacy of ropivacaine is 6 to 12 hours. It seemed appropriate to compare the 2 groups in terms of infiltration efficacy, in order to assess whether infiltration was beneficial or not.
研究概览
简要总结
Compare pain at H6 post-op.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over 18
- •Patients scheduled for thermodestructive hemorrhoidal surgery (RAFAELO® procedure)
- •Patient able to understand the protocol and having given written informed consent to participate in the study
- •Patient affiliated to the social security system or entitled beneficiary
排除标准
- •Patient < 18 years
- •Previous hemorrhoidectomy surgery (LONGO technique)
- •Patient with previous pexy ligation procedure (HAL-RAR technique)
- •Patients with known hypersensitivity to local anaesthetics or their ingredients
- •Patient on long-term (>1 month) analgesic treatment (Level II and III)
- •Patient participating in another interventional clinical research protocol involving a drug or a clinical investigation of a medical device
- •Pregnant, breast-feeding or childbearing patient without contraception
- •Patient under guardianship or deprived of liberty
结局指标
主要结局
Visual analogue scale (VAS) at H6 post-op (6 hours after the start of the procedure). The H6 criterion was retained, since the duration of efficacy of ropivacaine is 6 to 12 hours. It seemed appropriate to compare the 2 groups in terms of infiltration efficacy, in order to assess whether infiltration was beneficial or not.
Visual analogue scale (VAS) at H6 post-op (6 hours after the start of the procedure). The H6 criterion was retained, since the duration of efficacy of ropivacaine is 6 to 12 hours. It seemed appropriate to compare the 2 groups in terms of infiltration efficacy, in order to assess whether infiltration was beneficial or not.
次要结局
未报告次要终点
研究者
Chloé MOREAU
Scientific
Centre Hospitalier Departemental Vendee
研究点 (3)
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