Effect of Topical Lidocaine on Warm and Cold Sensation in Healthy Individuals - a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Paradoxical heat sensation (PHS)
研究概览
简要总结
The purpose of the present study is to systematically test the occurrence of paradoxical and illusory responses to cold and warm stimuli in healthy volunteers with artificial sensory loss.
详细描述
Efficient thermal sensation is important for adequate behavioral response to cold or warm stimuli and early signs of neuropathy can be changes in the thermal sensation.
Alterations in thermal perception can results in paradoxical heat sensation (a warm perception when the skin is cooled) or a peculiar/burning sensation when the skin is stiumlated with simultaneous warm and cold (a "thermal grill").
Clarifying the occurrence of these paradoxical and illusory sensations, may help understanding early signs of peripheral neuropathy as well as thermal sensory perception.
The investigators plan to conduct a study on thermal sensory perception using a model of sensory loss in healthy volunteers and systematically test the occurrence of paradoxical heat sensations and responses to the thermal grill.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Age between 18 and 40 years
- •Participant is able and willing to give informed consent.
排除标准
- •Unable to understand and speak Danish
- •Non-cooperative
- •Chronic pain or acute pain the past week lasting more than 4 hours or pain on the day of investigation
- •Pain medication within the last week
- •Medication within the last week that can affect assessment
- •Psychiatric or neurological disease and diseases that may affect the assessment
- •Sensory disturbances
- •History or symptoms of significant diseases (e.g. psychiatric or neurological disease, diseases that may affect the assessment, sensory disturbances, cancer, diabetes mellitus, liver diseases, kidney diseases, cardiovascular diseases)
- •Pregnancy or lactation
- •Jetlag or sleep deprivation
- •Alcohol or drug abuse
- •Consumption of cannabis the last 4 weeks and consumption of alcohol in the last 48 hours
- •Any abnormality of the skin or of vascular origin at application site
- •History of hypersensitivity to lidocaine, other amide-type anesthetics, or other contents of the lidocaine or vehicle
结局指标
主要结局
Paradoxical heat sensation (PHS)
时间窗: 45 minutes
Number of PHS responders on arm treated with lidocaine 45 minutes after drug application and Number of PHS responders on arm treated with ethanol 45 minutes after drug application
次要结局
- Pain intensity of the Thermal Grill (TG)(90 minutes)
- Thermal Grill (TG)(20 minutes before drug application)
- Quality of the Thermal Grill (TG)(75 minutes)
- Paradoxical heat sensation (PHS)(30 minutes before drug application)
- Intensity of unpleasantness of the Thermal Grill (TG)(95 minutes)
- Intensity of cold of the Thermal Grill (TG)(95 minutes)
- Intensity of warm of the Thermal Grill (TG)(95 minutes)