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NCT04036305 · ClinicalTrials.gov registry record
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
A clinical trial of Anesthesia, Local and Ehlers-Danlos Syndrome, sponsored by Vanderbilt University Medical Center.
- Active
- Registry status
- 230
- Enrollment target
- 1
- Study location
NCT04036305: Active study of Anesthesia, Local and Ehlers-Danlos Syndrome, sponsored by Vanderbilt University Medical Center.
NCT04036305 is a study of Anesthesia, Local and Ehlers-Danlos Syndrome that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 230 participants, above the 70-participant average among 18 other Anesthesia, Local trials with a reported enrollment target (229% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04036305, a study of Anesthesia, Local and Ehlers-Danlos Syndrome, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 230 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- DRUG 0.9% Sodium Chloride Injection
- DRUG Lidocaine Injection 2%
- DRUG Bupivacaine Injection 0.5%
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2019-07-26 |
| Est. Completion | 2029-12-31 |
What the registry record for NCT04036305 still lists
NCT04036305 is an observational study that tracks outcomes without assigning an intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 70-participant average among 18 other Anesthesia, Local trials with a reported enrollment target (229% higher).
The record links to 2 conditions, with Anesthesia, Local appearing as the primary indexed condition, and to 3 interventions - of which 0.9% Sodium Chloride Injection is the first listed.
NCT04036305 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04036305 about?
NCT04036305 is a clinical study titled "Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers". 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 proble...
What is the current status of trial NCT04036305?
This trial is currently active not recruiting. The enrollment target is 230 participants. The study started on 2019-07-26. Estimated completion is 2029-12-31.
What conditions does trial NCT04036305 study?
This clinical trial studies the following conditions: Anesthesia, Local, Ehlers-Danlos Syndrome.
What interventions are being tested in trial NCT04036305?
The interventions under investigation include: 0.9% Sodium Chloride Injection (DRUG), Lidocaine Injection 2% (DRUG), Bupivacaine Injection 0.5% (DRUG).
Who is sponsoring clinical trial NCT04036305?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04036305 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04036305's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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