Healthy Volunteers Clinical Trial
Official title:
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
Verified date | August 2011 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
The purpose of this study is to compare the effect of intravenous ropivacaine and lidocaine
on the receptive field of primary sensory afferents and their influence on the vascular bed.
*Trial with medicinal product
Status | Completed |
Enrollment | 34 |
Est. completion date | July 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion criteria: 1. Male 2. Age: 18 - 65 years 3. Weight: 50-100kg 4. Height: 155-195cm 5. Signed and dated informed consent 6. Sufficient command of German language Exclusion criteria: 1. Contraindications to the class of drugs under study 2. Vulnerable subjects (intellectually or mental impaired) 3. Known hypersensitivity to class of drugs or the investigational product 4. Drug abuse 5. Known peripheral neuropathies 6. Diabetes mellitus 7. Chronic alcohol consumption 8. Congestive heart disease 9. Participants of other studies during study period 10. Smoker |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Clinical Trial Center | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2) | 1 year | No |
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