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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00900913
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : August 8, 2011
Information provided by:
University of Zurich

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: ropivacaine (Naropin) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Systemic Ropivacaine on Hyperalgesia, Flare Reaction and Peripheral
Study Start Date : January 2010
Primary Completion Date : May 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: ropivacaine (Naropin)
    intravenous infusion 1 mg/kg bw
    Other Name: Naropin

Primary Outcome Measures :
  1. Aera of flare reaction (cm2), area of primary and secondary hyperalgesia (cm2) [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00900913

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

Responsible Party: Dr. Konrad Maurer, Institute of Anesthesiology Identifier: NCT00900913     History of Changes
Other Study ID Numbers: StV 24-2008
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: August 8, 2011
Last Verified: August 2011

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