Evaluation of mepivacaine ED95 for peripheral nerve blocks using ultrasound guidance
| ISRCTN | ISRCTN15749962 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15749962 |
| Protocol serial number | N/A |
| Sponsor | University of Bern |
| Funders | Universität Bern, Swiss Society of Anaesthesiology and Reanimation (SGAR) (Switzerland) - scientific fund |
- 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
Scientific
Department of Anaesthesiology
University of Bern
Inselspital
Bern
3010
Switzerland
| urs.eichenberger@insel.ch |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Up-and-down method study, patient is their own control. Volunteers and physician performing the block are blinded to the volume injected. |
| Secondary study design | Non randomised study |
| Scientific title | Evaluation of mepivacaine ED95 for peripheral nerve blocks using ultrasound guidance |
| Study objectives | 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(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) studied | 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 Applicable |
| Drug / device / biological / vaccine name(s) | Mepivacaine |
| Primary outcome measure(s) |
Block success: complete sensory block within 20 minutes in the skin area of the blocked ulnar nerve tested by pinprick. |
| Key secondary outcome measure(s) |
Duration of block |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 17 |
| Key inclusion criteria | 1. Healthy volunteers 2. Aged more than 18 and less than 70 years |
| Key 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 |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
University of Bern
Bern
3010
Switzerland
3010
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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.
