healthy volunteers
Conditions
Interventions
Group 1: 12 volunteers are received an ultrasound guided nerve block with 22.5mg Ropivacain and 0.2ml sodium and 5ml sodium intravenously as a placebo.
Group 2: 12 volunteers are received an ultrasoun
Sponsors
Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
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 local anaesthetics and dexmedetomidine, 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, hypotony, unreliability and/or lack of cooperation and mobility, other objections to participate in the study in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the prolongation of sensory and motor blockade of the ulnar nerve by dexmedetomidine added to ropivacaine. Sensory and motor block will be evaluated as follows: Prior the block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min, 60 min, after the block and then every 30 min until complete recovery. Evaluation of sensory scores: A pinprick test in comparison with the contralateral area propria of the ulnar nerve will be performed (0% = no difference to the contra lateral side; 100% = complete sensory loss). Evaluation of motor scores: -3 = no difference, adduction against contra-force possible -2 = slight difference, adduction against slight contra-force hardly possible -1 = significant difference, adduction without contra-force hardly possible -0 = no active adduction possible, paralysis The tests will be performed until complete recovery. Results will be documented. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome parameter is the site of action (systemic versus local). Test timepoints are the same because it is a blind study. | — |
Countries
Austria
Contacts
Public ContactDaniela Marhofer
Medizinsiche Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Outcome results
None listed