Effects of Buprenorphine on Ulnar Nerve Motor Block

This study has been terminated.
(Not enough could be recruted)
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00949299
First received: July 29, 2009
Last updated: March 14, 2014
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: buprenorphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Buprenorphine on Ulnar Nerve Motor Block

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: buprenorphine
    intradermal injection
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949299

Locations
Switzerland
University Hospital Zurich, Institut of Anaesthesiology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Konrad Maurer, MD Oberarzt Institute of Anesthesiology
  More Information

Additional Information:
No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00949299     History of Changes
Other Study ID Numbers: Stv 2/2009
Study First Received: July 29, 2009
Last Updated: March 14, 2014
Health Authority: Switzerland: SPUK, spezialisierte Unterkommission Anästhesie/Chirurgie
Switzerland: Ethikkommission
Switzerland: Swissmedic

Additional relevant MeSH terms:
Buprenorphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014