Clinical trial

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

Name

190957

Description

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. We 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 arms

Trial start

2019-07-26

Estimated PCD

2025-12-31

Trial end

2025-12-31

Treatment

0.9% Sodium Chloride Injection

All participants will be injected subcutaneously with a single 0.5ml dose

Arms:

EDS Patients, Healthy Volunteers

Other names:

Saline

Lidocaine Injection 2%

All participants will be injected subcutaneously with a single 0.5ml dose

Arms:

EDS Patients, Healthy Volunteers

Other names:

Xylocaine, lignocaine

Bupivacaine Injection 0.5%

All participants will be injected subcutaneously with a single 0.5ml dose

Arms:

EDS Patients, Healthy Volunteers

Other names:

marcaine

Size

230

Primary endpoint

Delta Pain Scores Lidocaine at 5 min

5 minutes post-injection

Eligibility 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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA samples from saliva will be collected in a subset of individuals for possible future analysis.'}, 'enrollmentInfo': {'count': 230, 'type': 'ESTIMATED'}}

Updated at

2023-12-05

1 organization

3 products

3 indications

Organization

Vanderbilt University Medical Center

Product

0.9% Sodium Chloride

Indication

Ehlers-Danlos Syndrome

Indication

Indication

Product

Product