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

• Conditions: Anesthesia, Local; Ehlers-Danlos Syndrome
• Interventions: Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2%; Drug: Bupivacaine Injection 0.5%

• Registration Number: NCT04036305
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-25
• Study Start: 2019-07-26
• Study First Posted: 2019-07-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 230

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

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Exclusion Criteria

• Known allergy to Lidocaine or Bupivacaine
• Unable to provide informed consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EDS Patients	0.9% Sodium Chloride Injection	Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Healthy Volunteers	Bupivacaine Injection 0.5%	Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Healthy Volunteers	Lidocaine Injection 2%	Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
EDS Patients	Lidocaine Injection 2%	Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
EDS Patients	Bupivacaine Injection 0.5%	Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Healthy Volunteers	0.9% Sodium Chloride Injection	Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome

Primary Outcome Measures

Name	Time	Method
Delta Pain Scores Lidocaine at 5 min	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).

Secondary Outcome Measures

Name	Time	Method
Delta Pain Scores Bupivacaine at 5 min	5 min	Difference between the pain score at the bupivacaine 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).
Delta Pain Scores Bupivacaine at 30 min	30 min	Difference between the pain score at the bupivacaine 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).
Delta Pain Scores Lidocaine at 30 min	30 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).

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States