Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• 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/ct2/show/NCT04036305
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Satish R Raj, MD MSCI
• 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

Ehlers-Danlos Syndrome

Anesthesia, Local

Intervention(s)

Drug: 0.9% Sodium Chloride Injection

Drug: Lidocaine Injection 2%

Drug: Bupivacaine Injection 0.5%

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 Lidocaine at 30 min [Time Frame: 30 min]

Delta Pain Scores Bupivacaine at 5 min [Time Frame: 5 min]

Secondary ID(s)

190957

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Calgary