Ehlers-Danlos SyndromeNCT04036305
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
An observational study of Ehlers-Danlos Syndrome and Anesthesia, Local, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ehlers-Danlos Syndrome, Anesthesia, Local
- What is being tested?
- 0.9% Sodium Chloride Injection, Lidocaine Injection 2% and Bupivacaine Injection 0.5%
- Type of treatment
- Injection or infusion
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2019to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: EDS patients and non-EDS participants
Who may be able to join
- 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
Who cannot join
- Known allergy to Lidocaine or Bupivacaine
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the 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.
- Conditions
- Ehlers-Danlos Syndrome, Anesthesia, Local
- Being tested
- 0.9% Sodium Chloride Injection, Lidocaine Injection 2%, Bupivacaine Injection 0.5%
- Keywords
- Ehlers-Danlos Syndrome, Local Anesthesia Resistance
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% Sodium Chloride InjectionDrug
Also called Saline
All participants will be injected subcutaneously with a single 0.5ml dose
Lidocaine Injection 2%Drug
Also called Xylocaine, lignocaine
All participants will be injected subcutaneously with a single 0.5ml dose
Bupivacaine Injection 0.5%Drug
Also called marcaine
All participants will be injected subcutaneously with a single 0.5ml dose
| Study group | Role | What they receive |
|---|---|---|
| EDS Patients | Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome Receives: Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2%; Drug: Bupivacaine Injection 0.5% | |
| Healthy Volunteers | Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome Receives: Drug: 0.9% Sodium Chloride Injection; Drug: Lidocaine Injection 2%; Drug: Bupivacaine Injection 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 minutes post-injection
Secondary outcomes (3)
Delta Pain Scores Lidocaine at 30 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).
Measured: 30 min
Delta Pain Scores Bupivacaine at 5 min
Difference between the pain score at the bupivacaine 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).
Measured: 5 min
Delta Pain Scores Bupivacaine at 30 min
Difference between the pain score at the bupivacaine 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).
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start26 Jul 2019
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, Satish R. Raj, Vanderbilt University Medical Center
- Investigators
- Satish R Raj, MD MSCI, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036305
- Sponsor's protocol ID
- 190957
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2019
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No