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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04036305
• Other study ID #: 190957
• Status: Enrolling by invitation
• Start date: July 26, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 230
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Ehlers-Danlos Syndrome
• Syndrome

Intervention

Drug:
• 0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
• Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
• Bupivacaine Injection 0.5%
All participants will be injected subcutaneously with a single 0.5ml dose

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	University of Calgary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta Pain Scores Lidocaine at 5 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).	5 minutes post-injection
Secondary	Delta Pain Scores Lidocaine at 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).	30 min
Secondary	Delta Pain Scores Bupivacaine at 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).	5 min
Secondary	Delta Pain Scores Bupivacaine at 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).	30 min