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Clinical Trials/NCT04036305
NCT04036305Active, not recruitingNot Applicable

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

Vanderbilt University Medical Center1 site in 1 country230 target enrollmentStarted: July 26, 2019Last updated:
Conditions
Interventions
Drugs

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Satish R. Raj

Adjunct Associate Professor of Medicine

Vanderbilt University Medical Center

Study Sites (1)

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