What side effects are associated with this type of intervention?

Local anesthetic treatments, including nerve blockades, for Ehlers-Danlos Syndrome (EDS) can have side effects such as increased pain, transient lower limb numbness, paraesthesias, and superficial burns. Additionally, patients with EDS often report local anesthetic resistance, which can manifest as initial ineffectiveness or rapid dissipation of the anesthetic effect. General side effects of injection therapies may include local allergic reactions and sensory blocks extending to unintended areas.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Ehlers-Danlos Syndrome (EDS). Management of EDS typically focuses on symptomatic relief and supportive care, including pain management, physical therapy, and sometimes surgical interventions. Local anesthetic nerve blockade, while not specifically approved for EDS, may be used off-label to manage pain in EDS patients, especially those who report resistance to local anesthetics. Comprehensive care often involves a multidisciplinary approach tailored to the individual's symptoms and needs.

What other types of research exist?

Promising alternatives for Ehlers-Danlos Syndrome patients considering treatment in 2024 include ultrasound-guided nerve blocks, peripheral nerve stimulators, multimodal analgesia, and sedation techniques like dexmedetomidine.

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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is investigating how well numbing medicines work for people with EDS. These patients often say these medicines don't work properly for them. The study aims to find out if the problem is that the medicine doesn't work, stops working too soon, or takes too long to start.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes post-injection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lidocaine

Secondary study objectives

Lidocaine

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 2Eligibility criteria met

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.