A Mechanistic Evaluation of the Nociceptive Desensitization Induced by Repeated Administration of Topical Local Anaesthetic Mixture of Lidocaine and Prilocaine (EMLA) in a Model of Histaminergic and Non-histaminergic Itch.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Superficial blood perfusion
研究概览
简要总结
In this experiment, the investigators would like to study if the repeated application of local cuaneous anaesthetic EMLA cream will reduce itch induced by small needles from the plant mucuna pruriens (also known as cowhage) and histamine (an itch proving substance formed in the body).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
The participant are blind about the location of EMLA and placebo application
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •18-60 years
- •Speak and understand English
排除标准
- •Pregnancy or lactation
- •Drug addiction defined as any use of cannabis, opioids or other drugs
- •Previous or current neurologic, musculoskeletal or mental illnesses
- •Lack of ability to cooperate
- •Current use of medications that may affect the trial
- •Skin diseases
- •Consumption of alcohol or painkillers 24 hours before the study days and between these
- •Acute or chronic pain
- •Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)
- •Known history of anaphylactic shock, or local allergy (contact dermatitis) to lidocaine, prilocaine or other local anaesthetics of the amide type.
研究组 & 干预措施
EMLA
干预措施: EMLA (lidocaine) +Itch (Histamine and cowhage) (Drug)
结局指标
主要结局
Superficial blood perfusion
时间窗: Change from baseline, up to three days after the first session
is measured by a Speckle contrast imager (FLPI, Moor Instruments, England).
Warm Detection Thresholds and Heat Pain Thresholds
时间窗: Change from baseline, up to three days after the first session
The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Pain rating
时间窗: only on day 3 (third session)
The subject will rate the pain for 9 min by using a a visual analog scale (VAS) on a tablet. This scale goes from 0 to 100. 0 indicates 'no pain' and 100 indicates 'worst imaginable pain'.
Pain to Supra-threshold Heat Stimuli
时间窗: Change from baseline, up to three days after the first session
The tests for thermal sensation will all be performed using a PATHWAY ATS (Medoc Ltd, Israel) thermal sensory testing device
Alloknesis
时间窗: Change from baseline, up to three days after the first session
Alloknesis is measured by using mildly pruritic, non-painful von Frey nylon filaments of a predetermined intensity (generally 5-30 miliNewton of force).
Mechanical Pain Thresholds and Sensitivity
时间窗: Change from baseline, up to three days after the first session
This test is performed using a pin-prick set (Aalborg University, Aalborg). The set consists of 8 needles each having a diameter of 0.6 mm and different force applications: 0.8, 1.6, 3.2, 6.4, 12.8, 25.6, 50.1 and 60.0 g
次要结局
- Itch rating(only on day 3 (third session))
研究者
Silvia Lo Vecchio
Principal Investigator
Aalborg University