Anesthesia, Local Clinical Trial
Official title:
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Verified date | November 2023 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Local anesthetic resistance is commonly reported by patients with EDS. However, there are no objective data on the occurrence of local anesthetic resistance in EDS patients and in healthy volunteers. The investigators propose to collect such objective data on the frequency of drug resistance and whether any problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.
Status | Active, not recruiting |
Enrollment | 155 |
Est. completion date | June 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria - EDS patients with genetically proven non-hypermobile EDS - Healthy participants, no EDS - Able and willing to provide informed consent Exclusion Criteria: - Known allergy to Lidocaine - Unable to provide informed consent |
Country | Name | City | State |
---|---|---|---|
Canada | Cardiovascular Autonomic Research Lab, University of Calgary | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | Vanderbilt University Medical Center |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ] | Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control [non-injected] region) to 3 (same or worse than the control region). | 5 minutes post-injection | |
Secondary | Delta Pain Scores Lidocaine at 30 min | Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control [non-injected] region) to 3 (same or worse than the control region). | 30 minutes post-injection |
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