Nerve block
Conditions
Interventions
Group 1: 3ml (=15mg) of original Ropivacaine (= Naropin) 0,5% perineurally administered at the Nervus ulnaris on day 1 with consecutive wash-out phase of at least 7 days.
Group 2: 3ml (=15mg) of orig
Sponsors
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Healthy males - 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 - 18-60 years old inclusive - Clearly detectable ulnar nerve at the non-dominant arm in ultrasound evaluation, 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 the ulnar nerve is 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 - History of alcohol or illicit substance abuse (>2 drinks/day, defined according to USDA Dietary Guidelines 2015) - Other objections to study participation in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: Duration of sensory nerve blockade | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective: - Duration of motor blockade - Onset time of sensory nerve blockade - Onset time of motor blockade - pH Value of the LA - PK Parameter (Cmax, tmax, t1/2, AUC, CL, Vd) | — |
Countries
Austria
Contacts
Public ContactMarkus Zeitlinger
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Outcome results
None listed