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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04036305
Date of registration: 25/07/2019
Prospective Registration: Yes
Primary sponsor: Vanderbilt University Medical Center
Public title: Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Scientific title: Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Date of first enrolment: July 26, 2019
Target sample size: 230
Recruitment status: Enrolling by invitation
URL:  https://clinicaltrials.gov/show/NCT04036305
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
United States
Contacts
Name:     Satish R Raj, MD MSCI
Address: 
Telephone:
Email:
Affiliation:  Vanderbilt University Medical Center
Key inclusion & exclusion criteria

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 or Bupivacaine

- Unable to provide informed consent



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Anesthesia, Local
Ehlers-Danlos Syndrome
Intervention(s)
Drug: 0.9% Sodium Chloride Injection
Drug: Bupivacaine Injection 0.5%
Drug: Lidocaine Injection 2%
Primary Outcome(s)
Delta Pain Scores Lidocaine at 5 min [Time Frame: 5 minutes post-injection]
Secondary Outcome(s)
Delta Pain Scores Bupivacaine at 30 min [Time Frame: 30 min]
Delta Pain Scores Bupivacaine at 5 min [Time Frame: 5 min]
Delta Pain Scores Lidocaine at 30 min [Time Frame: 30 min]
Secondary ID(s)
190957
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Calgary
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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