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

University of Calgary

Status and phase: Active, not recruiting; Phase 4

Conditions: Ehlers-Danlos Syndrome; Anesthesia, Local

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05603741

REB22-1157

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 155 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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155 participants in 1 patient group

Receiving Local Anesthetic Injection

Other group

Description:

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

Treatment:

Drug: Lidocaine Injection 2%

Drug: 0.9% Sodium Chloride Injection