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ISRCTN
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ISRCTN15749962
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ClinicalTrials.gov identifier
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Public title
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Evaluation of mepivacaine ED95 for peripheral nerve blocks using ultrasound guidance
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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To determine the 50% Effective Dose (ED50) and 95% Effective Dose (ED95) volume of 1% mepivacaine relative to the cross-sectional area of the ulnar nerve using ultrasound guidance for performance of an adequate sensory nerve block.
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Ethics approval
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Ethics approval received from the local ethics committee (Kantonale Ethikkommission Bern [KEK]) on the 6th June 2006 (ref: 76/06).
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Study design
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Up-and-down method study, patient is their own control. Volunteers and physician performing the block are blinded to the volume injected.
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Countries of recruitment
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Switzerland
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Disease/condition/study domain
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Peripheral regional anaesthesia
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Participants - inclusion criteria
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1. Healthy volunteers
2. Aged more than 18 and less than 70 years
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Participants - exclusion criteria
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1. Pregnancy
2. Sensory or motor abnormalities of the arm
3. Alcohol abuse
4. Intake of psychotropic drugs
5. Allergies to local anaesthetics
6. Intake of non-steroidal anti-inflammatory drugs the week preceding the study
7. Coagulation abnormalities
8. Coronary artery disease
9. Bacterical infection, systemic or local
10. Fever
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Anticipated start date
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01/08/2006
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Anticipated end date
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31/12/2006
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Status of trial
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Completed
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Patient information material
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Target number of participants
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20
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Interventions
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The ulnar nerve of the non-dominant forearm of the volunteer is scanned and its outer limit is tracked to calculate the cross-sectional area of the nerve. A short bevel facet tip ultrasound needle is advanced under direct ultrasonographic visualisation next to the nerve and the local anaesthetic is applied around the nerve.
The volume of local anaesthetic solution is calculated dependent on the measured cross-sectional area of the nerve, starting with 0.4 ml/mm^2 in the first volunteer. Each volunteer’s response determines the volume of local anaesthetic for the next volunteer. When sensory block is present within 20 minutes after injection, the volume for the next volunteer is decreased by 0.04 ml/mm^2. Conversely, when sensory block is insufficient, the volume for the next volunteer is increased by th same amount. After three cycles of dose reduction - dose augmentation the ED50 and ED 95 values will be calculated.
After the intervention, volunteers were controlled until total reversal of the block - that means 3 - 6 hours.
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Primary outcome measure(s)
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Block success: complete sensory block within 20 minutes in the skin area of the blocked ulnar nerve tested by pinprick.
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Secondary outcome measure(s)
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Duration of block.
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Sources of funding
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1. University of Bern (Switzerland) - Scientific fund of the Department of Anaesthesiology
2. Swiss Society of Anaesthesiology and Reanimation (SGAR) (Switzerland) - scientific fund
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Trial website
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Publications
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Contact name
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Dr
Urs
Eichenberger
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Address
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Department of Anaesthesiology
University of Bern
Inselspital
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City/town
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Bern
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Zip/Postcode
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3010
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Country
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Switzerland
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Email
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urs.eichenberger@insel.ch
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Sponsor
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University of Bern (Switzerland) - Scientific fund of the Department of Anaesthesiology
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Address
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Department of Anaesthesiology
Inselspital
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City/town
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Bern
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Zip/Postcode
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3010
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Country
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Switzerland
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Sponsor website:
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http://www.unibe.ch/eng/
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Date applied
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19/09/2007
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Last edited
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27/09/2007
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Date ISRCTN assigned
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27/09/2007
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