Investigation of antihyperalgesic effect... - topical lidocaine in i.d. capsaicin and sunburn model
- Conditions
- volunteer study with healthy volunteers using the intradermal capsaicin injection and UV-B sunburn as models of hyperalgesia
- Registration Number
- EUCTR2005-004426-93-AT
- Lead Sponsor
- Department of Anaesthesia and General Intensive Care Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
20 healthy volunteers (male:female=1:1) will be included in the study. Age 19-40 years, Body mass index 19-29, drug free, pain free.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Pregnancy, any disease, ongoing pain, previous exposure to UV-light (sun exposure)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: In this study the follwing hypotheses will be tested:<br>- Topical application of lidocain decreases the mechanical primary hyperalgesia of the skin compared to vehicle<br>- Thermal thresholds will be decreased by lidocain plaster;Secondary Objective: secondary hyperalgesia, intensitiy and area of inflammation;Primary end point(s): mechanical stimulus response after 12 hours of treatment with topical lidocaine plaster in the sunburn area and in the area of capsaicin injection compared to vehicle
- Secondary Outcome Measures
Name Time Method