Dislocation rates of perineural catheters: a volunteer study
- Conditions
- Healthy participants
- Registration Number
- DRKS00003494
- Lead Sponsor
- niversitätsklinik für Klinische Pharmakologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 20
•Healthy males 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 subject unable to understand the nature, scope and possible consequences of the study
•Anatomical abnormalities of the upper or lower limbs
•BMI >30 kg/m2
•Use of NSAID during the last 2 weeks
•Known allergy or hypersensitivity against mepivacaine or amino-amide local anaesthetics
•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 bradykardia
•Unreliability and/or lack of cooperation
•Inability to perform the standardized physical exercises (definition see below)
•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 Two different nerve catheters are located with the help of ultrasound. <br>Each volunteer has to perform physiotherapeutic exercises hourly all together for 3 times. After these exercises the volunteer has to undergo an ultrasound examination to evaluate catheter postion. <br>After 3 runs volunteers should do daily routine activities for 2hours.<br>After this procedure a final ultrasound examination take place. <br>The dislocation rate are evaluated. <br><br><br>
- Secondary Outcome Measures
Name Time Method no secondary outcome