NCT00900913已完成4 期
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
研究概览
简要总结
The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine on the receptive field of primary sensory afferents and their influence on the vascular bed.
*Trial with medicinal product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 65 years
- •Weight: 50-100kg
- •Height: 155-195cm
- •Signed and dated informed consent
- •Sufficient command of German language
排除标准
- •Contraindications to the class of drugs under study
- •Vulnerable subjects (intellectually or mental impaired)
- •Known hypersensitivity to class of drugs or the investigational product
- •Known peripheral neuropathies
- •Diabetes mellitus
- •Chronic alcohol consumption
- •Congestive heart disease
- •Participants of other studies during study period
结局指标
主要结局
Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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