Lidocaine for Ehlers-Danlos Syndrome

Overseen By Rasha Hamzeh, RN

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Calgary

Disqualifiers: Lidocaine allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effectiveness of local anesthetics like lidocaine and bupivacaine for individuals with Ehlers-Danlos Syndrome (EDS), a condition affecting connective tissues. Many with EDS report that these anesthetics either don't work well or wear off too quickly. Researchers will compare the experiences of those with EDS to healthy individuals to gather objective data on this issue. Individuals diagnosed with EDS based on specific criteria or those with healthy connective tissues can participate. Those with a lidocaine allergy should not participate in this trial. As a Phase 4 trial, this research focuses on understanding how these FDA-approved anesthetics can benefit more patients with EDS.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for these treatments?

A previous study found that lidocaine, often used as a patch, is generally safe for people, with most side effects being mild, such as skin reactions. For individuals with Ehlers-Danlos Syndrome (EDS), local anesthetics like lidocaine might not work as effectively, though this impacts efficacy, not safety.

Research has shown that bupivacaine has been successfully used for pain relief, such as during childbirth, and is also generally considered safe. However, like lidocaine, it may be less effective for EDS patients. Both lidocaine and bupivacaine are usually well-tolerated, with few serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using lidocaine injections for Ehlers-Danlos Syndrome (EDS) because, unlike typical treatments like pain relievers or physical therapy, lidocaine works by directly numbing the pain at its source. This local anesthetic targets the nerves in a specific area, potentially providing quicker and more localized pain relief without the systemic side effects common with oral medications. By offering a direct approach to managing pain, lidocaine may open new avenues for improving quality of life for EDS patients.

What evidence suggests that this trial's treatments could be effective for Ehlers-Danlos Syndrome?

This trial will evaluate the effectiveness of local anesthetics in individuals with Ehlers-Danlos Syndrome (EDS). Research has shown that people with EDS often find local anesthetics like lidocaine and bupivacaine less effective compared to those without EDS. For instance, 88% of people with EDS reported issues with local anesthetics not working properly, compared to 33% of those without EDS. This suggests a possible resistance to local anesthetics in people with EDS. However, one small study found that 81% of patients with various pain conditions experienced moderate or better pain relief from lidocaine. Both lidocaine and bupivacaine are considered effective and have manageable side effects for use in local anesthesia for EDS patients. ^{1 3 6 7 8}

Who Is on the Research Team?

Satish R Raj, MD MSCI

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You are a healthy participant without Ehlers-Danlos syndrome.

I have a genetic test confirming I have a type of EDS that is not hypermobile.

Able and willing to provide informed consent

Exclusion Criteria

I am unable to understand and give consent for treatment.

You have a known allergy to lidocaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive local anesthetic injections to assess resistance and effectiveness

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• 0.9% Sodium Chloride Injection
• Bupivacaine Injection 0.5%
• Lidocaine Injection 2%

Trial Overview 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.

How Is the Trial Designed?

Group I: Receiving Local Anesthetic Injection Experimental Treatment 2 Interventions

Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Published Research Related to This Trial

Viscous lidocaine can pose a high risk of overdose in pediatric patients due to their altered pharmacokinetics, making doses safe for adults potentially toxic for children.

Benzocaine is recommended as a safer alternative for treating painful mouth lesions in children, as it has a lower incidence of side effects, but if lidocaine must be used, clear and specific dosing instructions should be provided to parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine overdose: another preventable case? Gonzalez del Rey, J., Wason, S., Druckenbrod, RW.[2019]

In a pilot study involving 16 patients with various refractory peripheral neuropathic pain conditions, 81% reported moderate or better pain relief from using a topical lidocaine patch (Lidoderm) over an average of 6.2 weeks.

The treatment was well-tolerated, with only one patient experiencing mild skin irritation, suggesting that the Lidoderm patch could be a safe option for patients who have not found relief with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical lidocaine patch relieves a variety of neuropathic pain conditions: an open-label study. Devers, A., Galer, BS.[2022]

Bupivacaine and etidocaine, long-acting local anesthetics introduced in the 1980s, have been associated with severe adverse reactions, including fatalities, even with small doses, highlighting their potential risks.

Animal studies indicate that bupivacaine and etidocaine have higher systemic toxicity compared to lidocaine, leading to serious central nervous system and cardiovascular issues, which can result in life-threatening conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxic systemic reactions of bupivacaine and etidocaine. Bacsik, CJ., Swift, JQ., Hargreaves, KM.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6834718/

Resistance to local anesthesia in people with the Ehlers ... People with EDS report a dental local anesthetic injection that “did not work” at nearly three times the rate of those without EDS (88% vs. 33%).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04036305

Local Anesthetic Response in Ehlers-Danlos Syndrome ... Among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of ...

3. ctv.veeva.com ctv.veeva.com/study/local-anesthetic-response-in-ehlers-danlos-syndrome-eds-and-healthy-volunteers

Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS ... Among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of ...

4. researchgate.net researchgate.net/publication/337057878_Resistance_to_local_anesthesia_in_people_with_the_Ehlers-Danlos_Syndromes_presenting_for_dental_surgery

Resistance to local anesthesia in people with the Ehlers ... Conclusions: EDS survey respondents reported nearly three times the rate of LA non-response compared to non-EDS respondents, suggesting that LAs were less ...

5. withpower.com withpower.com/trial/phase-4-ehlers-danlos-syndrome-10-2022-91581

Lidocaine for Ehlers-Danlos Syndrome · Info for Participants ... Bupivacaine Injection 0.5% and Lidocaine Injection 2% will have tolerable side effects & efficacy for patients with Local Anesthesia, Ehlers-Danlos Syndrome ...

6. cdn.pfizer.com cdn.pfizer.com/pfizercom/products/material_safety_data/Bupivacaine_HCl__inj_09-Oct-2018_0.pdf

SAFETY DATA SHEET HYDROCHLORIC ACID. Material Name: Bupivacaine Hydrochloride Injection (Hospira,. Inc.) Bacterial Mutagenicity (Ames). Salmonella. Negative.

7. trials.arthritis.org trials.arthritis.org/trials/NCT04036305

Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS ... This study aims to assess the frequency and related issues around local anesthetic resistance in EDS patients.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217377024

Obstetric anaesthesia and Ehlers-Danlos syndrome ... Bupivacaine 0.5% provided adequate analgesia for labour. However, Caesarean section was performed because of failure to progress and cephalopelvic ...