Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers

NCT05603741 | Active Not Recruiting Phase 4

• 1 other identifier: REB22-1157
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

Local anesthetic resistance is commonly reported by patients with EDS. However, there are no objective data on the occurrence of local anesthetic resistance in EDS patients and in healthy volunteers. The investigators propose to collect such objective data on the frequency of drug resistance and whether any problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.

Conditions

Ehlers-Danlos Syndrome; Anesthesia, Local

Keywords

Ehlers-Danlos Syndrome; Local Anesthesia Resistance

Outcome Measures

Primary Outcomes (1)

• Delta Pain Scores Lidocaine at 5 min [ Time Frame: 5 minutes post-injection ]

  Difference between the pain score at the Lidocaine injection locations (compared to a control location) and the saline injection location (compared to a control location). The pain scale is .a 4 level scale from 0 ("absent sensation"), to 1 ("dull pressure"), to 2 ("sharp but less than a control \[non-injected\] region) to 3 (same or worse than the control region).

  5 minutes post-injection

Secondary Outcomes (1)

• Delta Pain Scores Lidocaine at 30 min

  30 minutes post-injection

Study Arms (1)

Receiving Local Anesthetic Injection

OTHER

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

Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2%

Interventions

0.9% Sodium Chloride Injection DRUG

All participants will be injected subcutaneously with a single 0.5ml dose

Also known as: Saline

Receiving Local Anesthetic Injection

Lidocaine Injection 2% DRUG

All participants will be injected subcutaneously with a single 0.5ml dose

Also known as: Xylocaine, Lignocaine

Receiving Local Anesthetic Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria
• EDS patients with genetically proven non-hypermobile EDS
• Healthy participants, no EDS
• Able and willing to provide informed consent

You may not qualify if:

• Known allergy to Lidocaine
• Unable to provide informed consent

Sponsors & Collaborators

• University of Calgary: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Cardiovascular Autonomic Research Lab, University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Interventions

Sodium Chloride; Lidocaine

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Satish R Raj, MD MSCI

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 3, 2022
• Study Start: November 10, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)