NCT04036305

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 230 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ehlers-Danlos Syndrome
• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	0.9% Sodium Chloride Injection	All participants will be injected subcutaneously with a single 0.5ml dose
DRUG	Lidocaine Injection 2%	All participants will be injected subcutaneously with a single 0.5ml dose
DRUG	Bupivacaine Injection 0.5%	All participants will be injected subcutaneously with a single 0.5ml dose

Timeline

• Start date: 2019-07-26
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2019-07-29
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States