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Local Anesthetic

Lidocaine for Ehlers-Danlos Syndrome

Phase 4
Waitlist Available
Led By Satish R Raj, MD MSCI
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
EDS patients with genetically proven non-hypermobile EDS
Be older than 18 years old
Must not have
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes post-injection
Awards & highlights

Summary

This trial will measure the frequency of local anesthetic resistance in EDS patients and healthy volunteers to understand if EDS contributes to it.

Who is the study for?
This trial is for individuals with genetically confirmed non-hypermobile Ehlers-Danlos Syndrome (EDS), those clinically diagnosed with hypermobile EDS, and healthy volunteers without EDS. Participants must be able to give informed consent. Those allergic to Lidocaine cannot join.Check my eligibility
What is being tested?
The study aims to objectively measure local anesthetic resistance in people with EDS compared to healthy individuals by using a common saltwater solution (0.9% Sodium Chloride) as a control and Lidocaine Injection 2% as the test intervention.See study design
What are the potential side effects?
While the saltwater injection should have no side effects, Lidocaine may cause reactions at the injection site, numbness beyond the target area, dizziness, or rarely more serious effects like allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a genetic test confirming I have a type of EDS that is not hypermobile.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes post-injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes post-injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Lidocaine
Secondary outcome measures
Lidocaine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Receiving Local Anesthetic InjectionExperimental Treatment2 Interventions
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
0.9% Sodium Chloride Injection
2018
Completed Phase 3
~250

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Local anesthetics, commonly used in nerve blockades, function by blocking sodium channels in nerve cells, which prevents the initiation and transmission of nerve impulses, thereby providing pain relief. This mechanism is particularly significant for Ehlers-Danlos Syndrome (EDS) patients, who often experience chronic pain due to joint instability and frequent injuries. However, EDS patients frequently report resistance to local anesthetics, which can complicate pain management. Understanding this resistance is crucial for developing effective pain management strategies, ensuring that EDS patients receive adequate and sustained relief from their symptoms.
Treatment of upper extremity reflex sympathetic dystrophy with joint stiffness using sympatholytic Bier blocks and manipulation.Erector Spinae Plane Block for anesthesia of open ventral hernia repair in severe Ankylosing Spondylitis.The Evolution of Cryoneurolysis for the Treatment of Shoulder, Hip, and Knee Pain: Where Are We Now and Where Will We Go? A Systematic Review.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
800 Previous Clinical Trials
875,015 Total Patients Enrolled
1 Trials studying Ehlers-Danlos Syndrome
230 Patients Enrolled for Ehlers-Danlos Syndrome
Vanderbilt University Medical CenterOTHER
869 Previous Clinical Trials
678,469 Total Patients Enrolled
1 Trials studying Ehlers-Danlos Syndrome
230 Patients Enrolled for Ehlers-Danlos Syndrome
Satish R Raj, MD MSCIPrincipal InvestigatorUniversity of Calgary
19 Previous Clinical Trials
1,271 Total Patients Enrolled
1 Trials studying Ehlers-Danlos Syndrome
230 Patients Enrolled for Ehlers-Danlos Syndrome

Media Library

Bupivacaine Injection 0.5% (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05603741 — Phase 4
Ehlers-Danlos Syndrome Research Study Groups: Receiving Local Anesthetic Injection
Ehlers-Danlos Syndrome Clinical Trial 2023: Bupivacaine Injection 0.5% Highlights & Side Effects. Trial Name: NCT05603741 — Phase 4
Bupivacaine Injection 0.5% (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603741 — Phase 4
~31 spots leftby Jan 2025