Effects of Buprenorphine on Ulnar Nerve Motor Block
This study is currently recruiting participants.
Verified August 2011 by University of Zurich
Sponsor:
University of Zurich
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00949299
First received: July 29, 2009
Last updated: August 5, 2011
Last verified: August 2011
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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 |
| Estimated Study Completion Date: | December 2011 |
| Estimated 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:
- Male
- Age: 18 - 65 years
- Weight: 50-100kg
- Height: 155-195cm
- Signed and dated informed consent
- Sufficient command of German language
Exclusion Criteria:
- Contraindications to the class of drugs under study
- Vulnerable subjects (intellectually or mental impaired)
- Known hypersensitivity to class of drugs or the investigational product
- Drug abuse
- Known peripheral neuropathies
- Diabetes mellitus
- Chronic alcohol consumption
- Congestive heart disease
- Participants of other studies during study period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949299
Contacts
| Contact: Konrad Maurer, MD | +41442559379 | konrad.maurer@usz.ch |
| Contact: Patrick Willimann, MD | +41442559156 | patrick.willimann@usz.ch |
Locations
| Switzerland | |
| University Hospital Zurich | Recruiting |
| Zurich, Switzerland | |
| Contact: Konrad Maurer, MD konrad.maurer@usz.ch | |
| Principal Investigator: Konrad Maurer, MD | |
| Sub-Investigator: Patrick Willimann, MD | |
| Sub-Investigator: Manuel Coradi, MD | |
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: | Dr. Konrad Maurer, Institute of Anesthesiology, University Hospital Zurich |
| ClinicalTrials.gov Identifier: | NCT00949299 History of Changes |
| Other Study ID Numbers: | Stv 2/2009 |
| Study First Received: | July 29, 2009 |
| Last Updated: | August 5, 2011 |
| Health Authority: | Switzerland: SPUK, spezialisierte Unterkommission Anästhesie/Chirurgie Switzerland: Ethikkommission Switzerland: Swissmedic |
Additional relevant MeSH terms:
|
Buprenorphine Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013