Effects of Buprenorphine on Ulnar Nerve Motor Block

This study is currently recruiting participants.
Verified August 2011 by University of Zurich
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00949299
First received: July 29, 2009
Last updated: August 5, 2011
Last verified: August 2011

July 29, 2009
August 5, 2011
January 2010
December 2011   (final data collection date for primary outcome measure)
The principal aim of the study is to measure the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00949299 on ClinicalTrials.gov Archive Site
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Effects of Buprenorphine on Ulnar Nerve Motor Block
Effects of Buprenorphine on Ulnar Nerve Motor Block

Recent reports showed that the opioid buprenorphine is a very potent sodium channel blocker. Buprenorphine not only exerts a strong antinociception, but also a long lasting antihyperalgesic effect. This antihyperalgesic effect is not observed for other clinically employed opioids but is common for local anaesthetics.

The principal aim of the study is to compare the speed of onset and the time of recovery of motor blockage achieved by lidocaine and buprenorphine, respectively. The investigators hypothesize that the blocking capacity of buprenorphine is equal to the one of lidocaine.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy Volunteers
Drug: buprenorphine
intradermal injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
Yes
Contact: Konrad Maurer, MD +41442559379 konrad.maurer@usz.ch
Contact: Patrick Willimann, MD +41442559156 patrick.willimann@usz.ch
Switzerland
 
NCT00949299
Stv 2/2009
Yes
Dr. Konrad Maurer, Institute of Anesthesiology, University Hospital Zurich
University of Zurich
Not Provided
Principal Investigator: Konrad Maurer, MD Oberarzt Institute of Anesthesiology
University of Zurich
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP