healthy volunteers
Conditions
Interventions
Group 1: 20 volunteers get a nerve block on each side on 3 days, that means 6 different examinations: Nervus medianus right and left, Nervus radialis right and left, Nervus ulnaris right and left
Sponsors
Medizinischen Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: •Healthy male volunteers •Healthy, according to the medical history, ECG, vital signs, laboratory results and physical examination as determined by the Investigator/Sub-Investigator •Signed written informed consent prior to inclusion in the study •18-55 years old inclusive •Clearly detectable nerves in ultrasound evaluation (radial, median and ulnar nerves), according to the main investigators opinion •BMI: 18 to 35 kg/m2 •Ability to understand the full nature and purpose of the study, including possible risks and side effects •Ability to co-operate with the investigator and to comply with the requirements of the entire study •Availability to volunteer for the entire study duration and willing to adhere to all protocol requirements
Exclusion criteria
Exclusion criteria: •Any clinically relevant abnormalities at ECG (12 leads) •Any clinically relevant abnormal physical findings •Any clinically relevant abnormal laboratory values indicative of physical illness •Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients of the study drug •History of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study •If one of the investigated nerves are not clearly visible in ultrasound •Relevant history of malignancy, of renal, hepatic, cardiovascular, respiratory, gastrointestinal, musculoskeletal, skin (particularly at the site of drug application), haematological, endocrine or neurological diseases that may interfere with the aim of the study •Any psychiatric illnesses •Using other medications during 1 week before the start of IMP application including OTC •Participation in another clinical study investigating another IMP within 1 month prior to screening •Blood donations during 6 weeks prior to this study or planned within 6 weeks after the last blood withdrawal •History of drug or alcohol abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2005) •Abnormal or special diet (e.g. vegetarian diet) •Other objections to study participation in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 20minutes evaluaiton of the sensory supply areas of the radial, median and ulnar nerves in healthy volunteers by a descriptive analysis(=marking the results on a photocopy of the participent´s hand) | — |
Secondary
| Measure | Time frame |
|---|---|
| After 20 minutes evaluation of intra-individual differences in the sensory supply areas of the radial, median and ulnar nerves in healthy volunteers(=marking the results on a photocopy of the participent´s hand) | — |
Countries
Austria
Contacts
Public ContactDaniela Marhofer
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Outcome results
None listed