Arm InjuriesNCT01982305
Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks
A study testing Simulator and Cadaver in people with Arm Injuries, run by Fundación Universitaria de Ciencias de la Salud.
Trial summary
The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arm Injuries
- What is being tested?
- Simulator and Cadaver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Anesthesia residents
Who cannot join
- Previous training in regional anesthesia techniques
About this study
Official title: Simulator Versus Cadaver Training to Perform Ultrasound-guided Axillary Nerve Bocks
The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.
Read the detailed description
Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.
- Conditions
- Arm Injuries
- Being tested
- Simulator, Cadaver
- Medical subject headings
- Arm Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulatorProcedure or surgery
Axillary nerve anatomy lecture plus training with the simulator.
CadaverProcedure or surgery
Axillary nerve anatomy lecture plus training with the cadaver model.
| Study group | Role | What they receive |
|---|---|---|
| Simulator | Experimental | One training session with the simulator. Receives: Procedure: Simulator |
| Cadaver | Active comparator | One training session with a cadaver. Receives: Procedure: Cadaver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to locate axillary nerve in a cadaver
Measured: At the end of the procedure, expected average of 30 seconds
Secondary outcomes (1)
Time to identify axillary nerve in a cadaver
Measured: During the procedure, expected average of 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arm InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universitaria de Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luis E Reyes, MD, Principal investigator, Fundacion Universitaria de Ciencias de la SaludLuis A Muñoz, MD, Principal investigator, Fundacion Universitaria de Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982305
- Sponsor's protocol ID
- Acta No. 277 Aug 6, 2012
- Status last verified
- Nov 2013
- First submitted
- 6 Nov 2013
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulator Versus Cadaver Training to Perform Ultrasound-guided Axillary Nerve Bocks
- ClinicalTrials.gov ID
- NCT01982305
- Acronym / sponsor ID
- Acta No. 277 Aug 6, 2012
- Conditions
- Arm Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fundación Universitaria de Ciencias de la SaludUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.
Detailed description
Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simulator | Experimental | Procedure: SimulatorOne training session with the simulator. |
| Cadaver | Active comparator | Procedure: CadaverOne training session with a cadaver. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesia residents
Key exclusion criteria (1 listed)
- Previous training in regional anesthesia techniques
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimulatorAxillary nerve anatomy lecture plus training with the simulator. | Procedure or surgery | Simulator |
| CadaverAxillary nerve anatomy lecture plus training with the cadaver model. | Procedure or surgery | Cadaver |
Primary outcome
Time to locate axillary nerve in a cadaver
Time frame: At the end of the procedure, expected average of 30 seconds
1 secondary outcome
Time to identify axillary nerve in a cadaver
Time frame: During the procedure, expected average of 15 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis E Reyes, MD principal investigator
Fundacion Universitaria de Ciencias de la Salud
Luis A Muñoz, MD principal investigator
Fundacion Universitaria de Ciencias de la Salud
Questions about this trial
What is this clinical trial studying?
A study testing Simulator and Cadaver in people with Arm Injuries, run by Fundación Universitaria de Ciencias de la Salud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to locate axillary nerve in a cadaver (time frame: At the end of the procedure, expected average of 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.