NCT01982305

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

2 months

First QC Date

November 6, 2013

Last Update Submit

November 12, 2013

Conditions

Arm Injuries

Outcome Measures

Primary Outcomes (1)

  • Time to locate axillary nerve in a cadaver

    At the end of the procedure, expected average of 30 seconds

Secondary Outcomes (1)

  • Time to identify axillary nerve in a cadaver

    During the procedure, expected average of 15 seconds

Study Arms (2)

Simulator

EXPERIMENTAL

One training session with the simulator.

Procedure: Simulator

Cadaver

ACTIVE COMPARATOR

One training session with a cadaver.

Procedure: Cadaver

Interventions

SimulatorPROCEDURE

Axillary nerve anatomy lecture plus training with the simulator.

Simulator
CadaverPROCEDURE

Axillary nerve anatomy lecture plus training with the cadaver model.

Cadaver

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anesthesia residents

You may not qualify if:

  • Previous training in regional anesthesia techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arm Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Luis E Reyes, MD

    Fundacion Universitaria de Ciencias de la Salud

    PRINCIPAL INVESTIGATOR

  • Luis A Muñoz, MD

    Fundacion Universitaria de Ciencias de la Salud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

November 13, 2013

Record last verified: 2013-11