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

NCT ID: NCT00900913

Last Updated: 2011-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Interventions

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ropivacaine (Naropin)

intravenous infusion 1 mg/kg bw

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Institute of Anesthesiology

Principal Investigators

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01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Locations

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Clinical Trial Center

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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StV 24-2008

Identifier Type: -

Identifier Source: org_study_id

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