Clinical evaluation of ED99 volumes in comparison to standard volumes of local anaesthetics for peripheral nerve blockade
- Conditions
- Patients undergoing surgery in forefoot
- Registration Number
- DRKS00004698
- Lead Sponsor
- Medizinische Universität Wien
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
•Patients undergoing plastic surgery in the supply area of the sciatic nerve in the lower extremity
•Age between 18 and 90 years old
•BMI <35kg/m2
•Written informed consent given by patients after being provided with detailed information about name, risks and scope of the clinical study as well as the expected desirable and adverse effects of the study drug
•No legal incapacity and/or the other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
•Known allergy or hypersensitivity against study drug or drug class
•Participation in another clinical study
•Abnormalities in ECG that are considered clinically relevant like AV-block or bradycardia
•Unreliability or lack of cooperation
•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 The main objective of the study is to investigate if the previously evaluated ED99 for ultrasound guided peripheral nerve blockade is transferable for surgical anaesthesia and analgesia.<br>After performing the block sensory is tested by pinbricks and motor block is tested by ability of plantar flexion and dorsoflexion in comparison with the contra lateral side.<br>Timepoints are prior block and ? 2 min ? 4 min ? 6 min ? 8 min ? 10 min ? 15 min ? 20 min ? 30 min ? 45 min? 60 min and every 30 min postoperatively.<br><br>
- Secondary Outcome Measures
Name Time Method no secondary endpoint