Evaluation of mepivacaine ED95 for peripheral nerve blocks using ultrasound guidance

ISRCTN ISRCTN15749962
DOI https://doi.org/10.1186/ISRCTN15749962
Secondary identifying numbers N/A
Submission date
19/09/2007
Registration date
27/09/2007
Last edited
06/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Urs Eichenberger
Scientific

Department of Anaesthesiology
University of Bern
Inselspital
Bern
3010
Switzerland

Email urs.eichenberger@insel.ch

Study information

Study designUp-and-down method study, patient is their own control. Volunteers and physician performing the block are blinded to the volume injected.
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titleEvaluation of mepivacaine ED95 for peripheral nerve blocks using ultrasound guidance
Study objectivesTo 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(s)Ethics approval received from the local ethics committee (Kantonale Ethikkommission Bern [KEK]) on the 6th June 2006 (ref: 76/06).
Health condition(s) or problem(s) studiedPeripheral regional anaesthesia
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Mepivacaine
Primary outcome measureBlock success: complete sensory block within 20 minutes in the skin area of the blocked ulnar nerve tested by pinprick.
Secondary outcome measuresDuration of block
Overall study start date01/08/2006
Completion date31/12/2006

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants20
Total final enrolment17
Key inclusion criteria1. Healthy volunteers
2. Aged more than 18 and less than 70 years
Key exclusion criteria1. 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
Date of first enrolment01/08/2006
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Switzerland

Study participating centre

University of Bern
Bern
3010
Switzerland

Sponsor information

University of Bern
University/education

Department of Anaesthesiology
Inselspital
Bern
3010
Switzerland

Website http://www.unibe.ch/eng/
ROR logo "ROR" https://ror.org/02k7v4d05

Funders

Funder type

University/education

Universität Bern
Government organisation / Universities (academic only)
Alternative name(s)
Universität Bern, Université de Berne, Universitas Bernensis, UniBE, جامعة برن, Бернскі ўніверсітэт, Бернски университет, Universitat de Berna, Bernská univerzita, Πανεπιστήμιο της Βέρνης, Universitato de Berno, Universidad de Berna, Berni Ülikool, Bernako Unibertsitatea, دانشگاه برن, Bernin yliopisto, Univèrsitât de Bèrna, Universidade de Berna, אוניברסיטת ברן, Università di Berna, ベルン大学, Берн университеті, 베른 대학교, Berno universitetas, Universiteit van Bern, Universitetet i Bern, Бернский университет, Bern Üniversitesi, Берн университеты, Бернський університет, 伯尔尼大学, UB
Location
Switzerland
Swiss Society of Anaesthesiology and Reanimation (SGAR) (Switzerland) - scientific fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 01/05/2009 06/08/2021 Yes No

Editorial Notes

06/08/2021: Publication reference and total final enrolment added.