Back to resultsEffect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
ropivacaine (Naropin)
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
- Male
- Age: 18 - 65 years
- Weight: 50-100kg
- Height: 155-195cm
- Signed and dated informed consent
- Sufficient command of German language
Exclusion criteria:
- Contraindications to the class of drugs under study
- Vulnerable subjects (intellectually or mental impaired)
- Known hypersensitivity to class of drugs or the investigational product
- Drug abuse
- Known peripheral neuropathies
- Diabetes mellitus
- Chronic alcohol consumption
- Congestive heart disease
- Participants of other studies during study period
- Smoker
Sites / Locations
- Clinical Trial Center
Outcomes
Primary Outcome Measures
Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00900913
Brief Title
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability
Official Title
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ropivacaine (Naropin)
Other Intervention Name(s)
Naropin
Intervention Description
intravenous infusion 1 mg/kg bw
Primary Outcome Measure Information:
Title
Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)
Time Frame
1 year
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Male
Age: 18 - 65 years
Weight: 50-100kg
Height: 155-195cm
Signed and dated informed consent
Sufficient command of German language
Exclusion criteria:
Contraindications to the class of drugs under study
Vulnerable subjects (intellectually or mental impaired)
Known hypersensitivity to class of drugs or the investigational product
Drug abuse
Known peripheral neuropathies
Diabetes mellitus
Chronic alcohol consumption
Congestive heart disease
Participants of other studies during study period
Smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Trial Center
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability
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