- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06219005
Ultrasound-guided Nerve Block Training Model and Evaluation Method
March 22, 2024 updated by: Duke University
Standardized Assessment of Emergency Physician Ultrasound-guided Nerve Block Training Using a Low-fidelity Simulation Model
The aim of this study is to assess emergency medicine physician knowledge and technical skill in performance of ultrasound-guided serratus anterior nerve block in a low-fidelity simulation model workshop and to determine the feasibility, acceptability, and usability of the training program.
By performing this study, the investigators hope to create a standardized training model which could potentially facilitate POCUS and critical procedural performance and thereby improve patient care.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rebecca G Theophanous, M.D., MHSc
- Phone Number: 919-684-8111
- Email: rebecca.theophanous@duke.edu
Study Contact Backup
- Name: Abha Singh
- Phone Number: 919-684-8111
- Email: abha.singh@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke University School of Medicine
-
Contact:
- Abha Singh
- Phone Number: 919-684-8111
- Email: abha.singh@duke.edu
-
Principal Investigator:
- Rebecca G Theophanous, M.D., MHSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Emergency medicine attending and resident physicians
Exclusion Criteria:
- ED nursing, ED technicians, and advanced practice physicians (APPs)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Emergency Medicine attending physicians and residents
|
workshop testing emergency physician knowledge and technical skills in performing ultrasound-guided nerve blocks in a simulation model
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physician knowledge assessment
Time Frame: 4 months
|
The investigators will assess ultrasound-guided serratus anterior nerve block in a simulation model using surveys at 1 month pre-intervention, post-intervention, and 3 months post-intervention (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree)
|
4 months
|
Physician technical skills assessment
Time Frame: 4 months
|
The investigators will assess ultrasound-guided serratus anterior nerve block in a simulation model using surveys at 1 month pre-intervention, post-intervention, and 3 months post-intervention (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
acceptability of our implementation strategy
Time Frame: 4 months
|
The investigators will evaluate EM physician education and simulation workshop implementation strategy acceptability using a post-intervention survey (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).
|
4 months
|
appropriateness of our implementation strategy
Time Frame: 4 months
|
The investigators will evaluate EM physician education and simulation workshop implementation strategy appropriateness using a post-intervention survey (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).
|
4 months
|
feasibility of our implementation strategy
Time Frame: 4 months
|
The investigators will evaluate EM physician education and simulation workshop implementation strategy feasibility using a post-intervention survey (Likert scale 0-5 with values of Strongly disagree, disagree, neutral, agree, strongly agree).
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Petrosoniak A, Herold J, Woolfrey K. Emergency medicine procedural skills: what are residents missing? CJEM. 2013 Jul;15(4):241-8. doi: 10.2310/8000.2013.130897.
- Sherbino J, Bandiera G, Frank JR. Assessing competence in emergency medicine trainees: an overview of effective methodologies. CJEM. 2008 Jul;10(4):365-71. doi: 10.1017/s1481803500010381.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
December 15, 2024
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
January 12, 2024
First Submitted That Met QC Criteria
January 12, 2024
First Posted (Actual)
January 23, 2024
Study Record Updates
Last Update Posted (Actual)
March 26, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00114989
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
All participant information will be confidential and restricted to the research study team.
Deidentified summary data will be made available after study completion for public and scientific community dissemination and future clinical improvements.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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