Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral Nerve Excitability

Healthy Volunteers Clinical Trial

Official title:

Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900913
• Other study ID #: StV 24-2008
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2008
• Last updated: August 5, 2011
• Start date: January 2010
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers
• Hyperalgesia

Intervention

Drug:
• ropivacaine (Naropin)
intravenous infusion 1 mg/kg bw

Locations

Country	Name	City	State
Switzerland	Clinical Trial Center	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2)		1 year	No