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

StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Primary completion date: Jan 2025 to Jan 2027
    • Study completion date: Jun 2025 to Jun 2027
    v6
  2. 2 versions Re-verified since Nov 29, 2023, no change to tracked fieldsv4-v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v3
  4. Start date changed from estimate of Nov 2022 to Nov 10, 2022
    • Interventions: 0.9% Sodium Chloride Injection (Drug), Bupivacaine Injection 0.5% (Drug), Lidocaine Injection 2% (Drug) to 0.9% Sodium Chloride Injection (Drug), Lidocaine Injection 2% (Drug)
    • Secondary endpoints: 3 to 1
    • Eligibility criteria shortened, about 2 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05603741
Lead Sponsor University of Calgary
Collaborators: Vanderbilt University Medical Center
Conditions
(from sponsor)		 Ehlers-Danlos Syndrome, Anesthesia, Local
Related terms Ehlers-Danlos Syndrome
Enrollment 155 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov