NCT04036305|Active Not Recruiting
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Sponsor study identifier
observational
230
1 country
1
Study Start
July 26, 2019
Actual (reported)Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2019
Actual (reported)July 26, 2019
Actual (reported)July 29, 2019
Actual (reported)December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Delta Pain Scores Lidocaine at 30 min
30 min
Delta Pain Scores Bupivacaine at 5 min
5 min
Delta Pain Scores Bupivacaine at 30 min
30 min
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
All participants will be injected subcutaneously with a single 0.5ml dose
All participants will be injected subcutaneously with a single 0.5ml dose
EDS patients and non-EDS participants
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
DNA samples from saliva will be collected in a subset of individuals for possible future analysis.
Satish R Raj, MD MSCI
Vanderbilt University Medical Center
First Submitted
July 25, 2019
First Posted
July 29, 2019
Study Start
July 26, 2019
Actual (reported)Primary Completion
December 31, 2029
EstimatedClinical Outcomes Mandible: Buffered 1% vs. Non-Buffered 1% Lidocaine
Optimal Lidocaine Buffering to Reduce Injection Pain in Local Anesthesia
All participants will be injected subcutaneously with a single 0.5ml dose
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 16, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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