Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
NCT ID: NCT04036305
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
230 participants
OBSERVATIONAL
2019-07-26
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
NCT05603741
Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers
NCT00889642
The Effect of Intravenous Lidocaine on Normal Sensation and Pain in Healthy Volunteers
NCT00657358
Cutaneous Administration of Local Anesthetic for Spine Injection Procedures
NCT00756301
Local Anesthesia and Pain Perception During an Amniocentesis
NCT00583011
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study aims to assess the frequency and related issues around local anesthetic resistance in EDS patients, including whether the problem is a lack of analgesia or a timing effect (short duration of action or delayed onset of action), and whether the problem relates only to some local anesthetics or whether there is a problem with the whole class of local anesthetics.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
EDS Patients
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
Bupivacaine Injection 0.5%
All participants will be injected subcutaneously with a single 0.5ml dose
Healthy Volunteers
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
Bupivacaine Injection 0.5%
All participants will be injected subcutaneously with a single 0.5ml dose
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
Bupivacaine Injection 0.5%
All participants will be injected subcutaneously with a single 0.5ml dose
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* EDS patients with genetically proven non-hypermobile EDS
* Healthy participants, no EDS
* Able and willing to provide informed consent
Exclusion Criteria
* Unable to provide informed consent
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Calgary
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Satish R. Raj
Adjunct Associate Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Satish R Raj, MD MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
190957
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.