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NCT00949299 Clinical Trial

Effects of Buprenorphine on Ulnar Nerve Motor Block

Healthy Volunteers Clinical Trial

Official title:
Effects of Buprenorphine on Ulnar Nerve Motor Block

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00949299
Other study ID # Stv 2/2009
Secondary ID
Status Terminated
Phase Phase 4
First received July 29, 2009
Last updated March 14, 2014
Start date January 2010
Est. completion date December 2011

Study information
Verified date August 2011
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: SPUK, spezialisierte Unterkommission Anästhesie/ChirurgieSwitzerland: EthikkommissionSwitzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• buprenorphine
intradermal injection

Locations
Country Name City State
Switzerland University Hospital Zurich, Institut of Anaesthesiology Zurich ZH

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 6 hours No
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