Contact information
Type
Scientific
Primary contact
Dr Urs Eichenberger
ORCID ID
Contact details
Department of Anaesthesiology
University of Bern
Inselspital
Bern
3010
Switzerland
urs.eichenberger@insel.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the local ethics committee (Kantonale Ethikkommission Bern [KEK]) on the 6th June 2006 (ref: 76/06).
Study design
Up-and-down method study, patient is their own control. Volunteers and physician performing the block are blinded to the volume injected.
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Peripheral regional anaesthesia
Intervention
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 volunteers 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.
Intervention type
Drug
Phase
Not Specified
Drug names
Mepivacaine
Primary outcome measures
Block success: complete sensory block within 20 minutes in the skin area of the blocked ulnar nerve tested by pinprick.
Secondary outcome measures
Duration of block.
Overall trial start date
01/08/2006
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy volunteers
2. Aged more than 18 and less than 70 years
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
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
Recruitment start date
01/08/2006
Recruitment end date
31/12/2006
Locations
Countries of recruitment
Switzerland
Trial participating centre
Department of Anaesthesiology
Bern
3010
Switzerland
Sponsor information
Organisation
University of Bern (Switzerland) - Scientific fund of the Department of Anaesthesiology
Sponsor details
Department of Anaesthesiology
Inselspital
Bern
3010
Switzerland
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Bern (Switzerland) - Scientific fund of the Department of Anaesthesiology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swiss Society of Anaesthesiology and Reanimation (SGAR) (Switzerland) - scientific fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary