healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Healthy male volunteers aged between 18 and 45 years - BMI < 30 kg/m2 - Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drug - No legal incapacity and/or other circumstances rendering the volunteer unable to understand the nature, scope and possible consequences of the study
Exclusion criteria
Exclusion criteria: - Anatomical abnormalities of the forearm identified by physical examination - Use of NSAID during the last 2 weeks - Known allergy or hypersensitivity against ropivacaine or other amino-amide LA - Participation in another clinical study within the last 4 weeks prior to study - Coagulopathy - Abnormalities in ECG that are considered clinically relevant like AV-block or bradycardia - Unreliability and/or lack of cooperation - Other objections to participate in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the sensory spread of the block. Evaluation takes place with pin brick tests and will be evaluated after 2, 4, 6, 8, 10, 15, 20, 30, 60, 90,120,150, 180minutes until sensibility is completely recovered. Complete blockade is achieved when VAS=3 within 20 minutes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time and duration of the block | — |
Countries
Austria
Contacts
Medizinische Universität Wien, Universitätsklinik für Anäesthesie, Allgemeine Intensivmedizin und Schmerztherapie