Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Delta Pain Scores Lidocaine at 5 min
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
EDS Patients
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Intervention: 0.9% Sodium Chloride Injection (Drug)
EDS Patients
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Intervention: Lidocaine Injection 2% (Drug)
EDS Patients
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Intervention: Bupivacaine Injection 0.5% (Drug)
Healthy Volunteers
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Intervention: 0.9% Sodium Chloride Injection (Drug)
Healthy Volunteers
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Intervention: Lidocaine Injection 2% (Drug)
Healthy Volunteers
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Intervention: Bupivacaine Injection 0.5% (Drug)
Outcomes
Primary Outcomes
Delta Pain Scores Lidocaine at 5 min
Time Frame: 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 Outcomes
- Delta Pain Scores Bupivacaine at 5 min(5 min)
- Delta Pain Scores Bupivacaine at 30 min(30 min)
- Delta Pain Scores Lidocaine at 30 min(30 min)
Investigators
Satish R. Raj
Adjunct Associate Professor of Medicine
Vanderbilt University Medical Center