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

NCT ID: NCT05603741

Last Updated: 2024-12-18

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

Clinical Phase

PHASE4

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-10

Study Completion Date

2027-06-30

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. 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.

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. This study is completing data originally collected during a 2019 EDS conference.

Conditions

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Ehlers-Danlos Syndrome Anesthesia, Local

Keywords

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Ehlers-Danlos Syndrome Local Anesthesia Resistance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Receiving Local Anesthetic Injection

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

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

Group Type OTHER

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

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

Other Intervention Names

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Saline Xylocaine Lignocaine

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
* Unable to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Satish R Raj, MD MSCI

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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Cardiovascular Autonomic Research Lab, University of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB22-1157

Identifier Type: -

Identifier Source: org_study_id