Clinical trial NCT04036305: Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Official title: Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ehlers-Danlos Syndrome
Anesthesia, Local
Keywords: Ehlers-Danlos Syndrome
Local Anesthesia Resistance
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2019-07-29
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EDS patients and non-EDS participants

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.

Eligibility criteria: 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

Primary outcomes:
measure: Delta Pain Scores Lidocaine at 5 min
timeFrame: 5 minutes post-injection
Secondary outcomes:
measure: Delta Pain Scores Lidocaine at 30 min
timeFrame: 30 min
measure: Delta Pain Scores Bupivacaine at 5 min
timeFrame: 5 min
measure: Delta Pain Scores Bupivacaine at 30 min
timeFrame: 30 min
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References: