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

NCT ID: NCT04036305

Last Updated: 2025-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-26

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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There was a prior large online questionnaire to better understand the issues around local anesthetic resistance. By November 2018, 933 EDS patients (total 1059 respondents) completed the survey, 99.2% of which had previously received local anesthetics. Among these patients, 88% reported that they have "had a problem with local anesthetic injection not working adequately or properly," while only 54% of respondents without EDS reported a similar problem. These data suggests that local anesthetic resistance might be more prevalent in patients with EDS than in the general population. If these findings are true, then this might have significant implications for the appropriate management of these patients during minor surgery and dental procedures.

This study aims to assess the frequency and related issues around local anesthetic resistance in EDS patients, including whether the problem is a lack of analgesia or a timing effect (short duration of action or delayed onset of action), and whether the problem relates only to some local anesthetics or whether there is a problem with the whole class of local anesthetics.

Conditions

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Ehlers-Danlos Syndrome Anesthesia, Local

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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EDS Patients

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

0.9% Sodium Chloride Injection

Intervention Type DRUG

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

Lidocaine Injection 2%

Intervention Type DRUG

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

Bupivacaine Injection 0.5%

Intervention Type DRUG

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

Healthy Volunteers

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

0.9% Sodium Chloride Injection

Intervention Type DRUG

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

Lidocaine Injection 2%

Intervention Type DRUG

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

Bupivacaine Injection 0.5%

Intervention Type DRUG

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

Interventions

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0.9% Sodium Chloride Injection

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

Intervention Type DRUG

Lidocaine Injection 2%

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

Intervention Type DRUG

Bupivacaine Injection 0.5%

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

Intervention Type DRUG

Other Intervention Names

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Saline Xylocaine lignocaine marcaine

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Known allergy to Lidocaine or Bupivacaine
* Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Calgary

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Satish R. Raj

Adjunct Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Satish R Raj, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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190957

Identifier Type: -

Identifier Source: org_study_id

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