The effect of extra-epineural administered dexmedetomidine: a volunteer study
- Conditions
- healthy volunteers
- Registration Number
- DRKS00003529
- Lead Sponsor
- Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 36
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Investigation of the prolongation of sensory and motor blockade of the ulnar nerve by dexmedetomidine added to ropivacaine. <br>Sensory and motor block will be evaluated as follows:<br>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.<br>Evaluation of sensory scores:<br>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). <br>Evaluation of motor scores:<br>-3 = no difference, adduction against contra-force possible<br>-2 = slight difference, adduction against slight contra-force hardly possible<br>-1 = significant difference, adduction without contra-force hardly possible<br>-0 = no active adduction possible, paralysis<br>The tests will be performed until complete recovery. Results will be documented.
- Secondary Outcome Measures
Name Time Method The secondary outcome parameter is the site of action (systemic versus local). Test timepoints are the same because it is a blind study.