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

155 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Lidocaine Injection 2% for Ehlers-Danlos Syndrome?

The research suggests that lidocaine can provide temporary pain relief, as seen in a study where lidocaine infiltration initially abolished pain in Ehlers-Danlos patients, although the effect was not long-lasting. Additionally, lidocaine patches have been effective in treating various neuropathic pain conditions, indicating potential benefits for pain management. ^{1 2 3 4 5}

Is lidocaine generally safe for use in humans?

Lidocaine, especially in patch form, is generally considered safe for humans with minimal risk of serious side effects, mainly causing mild skin reactions. However, caution is advised in children due to the risk of overdose, and bupivacaine, a related drug, has been associated with severe adverse reactions. ^{4 6 7 8 9}

How does the drug for Ehlers-Danlos Syndrome differ from other treatments?

The treatment for Ehlers-Danlos Syndrome using lidocaine and bupivacaine is unique because it combines two local anesthetics that are typically used for pain relief in other conditions, such as dental procedures and epidural anesthesia. This combination may offer a novel approach to managing pain in Ehlers-Danlos Syndrome, a condition with no standard treatment, by potentially providing longer-lasting and more effective pain relief. ^{10 11 12 13 14}

What is the purpose of this trial?

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.

Research Team

Satish R Raj, MD MSCI

Principal Investigator

University of Calgary

Eligibility Criteria

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.

People with clinically diagnosed hypermobile Ehlers-Danlos syndrome based on 2017 criteria.

Exclusion Criteria

I am unable to understand and give consent for treatment.

You have a known allergy to lidocaine.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Local anaesthetic resistance in a patient with Ehlers-Danlos syndrome undergoing caesarean section with continuous spinal anaesthesia. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Insufficient effect of local analgesics in Ehlers Danlos type III patients (connective tissue disorder). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of the lidocaine patch 5%, a targeted peripheral analgesic: a review of the literature. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Use of lidocaine patch 5% for chronic low back pain: a report of four cases. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Toxic systemic reactions of bupivacaine and etidocaine. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The Efficacy, Effectiveness and Safety of 5% Transdermal Lidocaine Patch for Chronic Low Back Pain: A Narrative Review. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Topical Lidocaine for Chronic Pain Treatment. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Lidocaine overdose: another preventable case? [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Plasma concentrations of lidocaine and its principal metabolites during intermittent epidural anesthesia. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized, double-blind comparison of bupivacaine and lidocaine for maxillary infiltrations. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Assessing the duration of mandibular soft tissue anesthesia. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Blood concentrations of lidocaine, mepivacaine and bupivacaine during caudal analgesia in children. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Tachyphylaxis associated with repeated epidural injections of lidocaine is not related to changes in distribution or the rate of elimination from the epidural space. [2016]