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

NCT04036305 | Active Not Recruiting

• 1 other identifier: 190957
• Study Type: observational
• Target: 230
• 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. We 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

  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 (3)

• Delta Pain Scores Lidocaine at 30 min

  30 min

• Delta Pain Scores Bupivacaine at 5 min

  5 min

• Delta Pain Scores Bupivacaine at 30 min

  30 min

Study Arms (2)

EDS Patients

Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome

Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2%; Drug: Bupivacaine Injection 0.5%

Healthy Volunteers

Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome

Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2%; Drug: Bupivacaine Injection 0.5%

Interventions

0.9% Sodium Chloride Injection DRUG

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

Also known as: Saline

EDS Patients; Healthy Volunteers

Lidocaine Injection 2% DRUG

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

Also known as: Xylocaine, lignocaine

EDS Patients; Healthy Volunteers

Bupivacaine Injection 0.5% DRUG

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

Also known as: marcaine

EDS Patients; Healthy Volunteers

Eligibility Criteria

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

Study Population

EDS patients and non-EDS participants

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 or Bupivacaine
• Unable to provide informed consent

Sponsors & Collaborators

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

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples from saliva will be collected in a subset of individuals for possible future analysis.

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Interventions

Sodium Chloride; Lidocaine; Bupivacaine

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

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor of Medicine

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: July 26, 2019
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)