- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454801
Expert Behaviors USGRA
Expert Behaviors in Ultrasound Guided Regional Anesthesia A Mixed-Methods Study
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Rongyu (Cindy) Jin
- Phone Number: 2016 416-603-5800
- Email: rongyu.jin@uhn.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This is a mixed methods assessment study to be completed at TWH. We will recruit 10 fellowship-trained regional anesthesiology and pain medicine staff anesthesiologists to perform USGRA blocks while being video-recorded. Here, we specifically define expert as a staff anesthesiologist who has completed a fellowship in regional anesthesia and/or chronic pain and has at least 6-years of post-fellowship clinical experience with USGRA.
Consent will also be sought from 180 patients undergoing USGRA for surgical procedures at TWH to have the block completed by an expert, as previously defined, and to have the procedure recorded.
Description
Inclusion Criteria:
- All elective patients coming to the regional BR at TWH aged 18-80
Exclusion Criteria:
- Any contraindication to USGRA (LA allergy, patient refusal, infection at injection site, etc.)
- Inability to read or speak or comprehend English fluently
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative behaviors of experts performing UGRA techniques during pre-procedural discussion
Time Frame: 1 hour before procedure
|
Reviewers will identify behaviors exhibited by the expert operators during pre-procedural discussion
|
1 hour before procedure
|
Qualitative behaviors of experts performing UGRA techniques during patient and equipment preparation
Time Frame: 0.5 hour before procedure
|
Reviewers will identify behaviors exhibited by the expert operators during patient and equipment preparation
|
0.5 hour before procedure
|
Qualitative behaviours of experts performing UGRA techniques during ultrasound scanning of the target area;
Time Frame: 10 minutes before procedure
|
Reviewers will identify behaviors exhibited by the expert operators during ultrasound scanning of the target area;
|
10 minutes before procedure
|
Qualitative behaviours of experts performing UGRA techniques during needle advancement and local anesthetic deposition around the target nerve(s)
Time Frame: during procedure
|
Reviewers will identify behaviors exhibited by the expert operators during needle advancement and local anesthetic deposition around the target nerve(s).
|
during procedure
|
Quantitative data on block effectiveness defined by blocks requiring top-up
Time Frame: 0-1 hour after procedure
|
number of top-up will be collected
|
0-1 hour after procedure
|
Quantitative data on block effectiveness defined by blocks requiring conversion to GA
Time Frame: 0-1 hour after procedure
|
Incidence will be documented in case conversion to GA is needed
|
0-1 hour after procedure
|
Quantitative data on time to surgical anesthesia
Time Frame: 0-1 hour after procedure
|
defined by final needle removal to surgical anesthesia
|
0-1 hour after procedure
|
Quantitative data on time to block completion
Time Frame: 0-1 hour after procedure
|
defined by needle insertion to final needle removal
|
0-1 hour after procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ki Jinn Chin, MD, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19-6238
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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