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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes post-injection
Awards & highlights

Study 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.

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

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
791 Previous Clinical Trials
868,579 Total Patients Enrolled
1 Trials studying Ehlers-Danlos Syndrome
230 Patients Enrolled for Ehlers-Danlos Syndrome
Vanderbilt University Medical CenterOTHER
856 Previous Clinical Trials
672,037 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest population size involved in this investigation?

"Affirmative. Clinicaltrials.gov displays that this medical trial, posted on November 10th 2022, is currently seeking participants. 155 volunteers must be sourced from 1 designated location."

Answered by AI

Are there opportunities to enrol in this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical investigation is actively seeking participants and was first posted on November 10th 2022; the last update occurred on November 18th 2022. The trial requires a pool of 155 volunteers from one single site."

Answered by AI

To what degree does this therapy present a risk to the patient?

"As this is a Phase 4 trial, indicating approval and data to support safety, the treatment was scored with a 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
2022. "Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05603741.
~50 spots leftby Jan 2025
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