Condition category
Signs and Symptoms
Date applied
19/09/2007
Date assigned
27/09/2007
Last edited
27/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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.

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

http://www.unibe.ch/eng/

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

Publication citations

Additional files

Editorial Notes