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

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00900913
First received: October 21, 2008
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
 Drug: ropivacaine (Naropin)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 34
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ropivacaine (Naropin)
    intravenous infusion 1 mg/kg bw
    Other Name: Naropin
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900913

Locations
Switzerland
Clinical Trial Center
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Dr. Konrad Maurer, Institute of Anesthesiology
ClinicalTrials.gov Identifier: NCT00900913     History of Changes
Other Study ID Numbers: StV 24-2008
Study First Received: October 21, 2008
Last Updated: August 5, 2011
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ropivacaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013