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NCT Number: NCT04036305

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 problems with local anesthesia are due to initial ineffectiveness or due to its effects dissipating too soon.

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Key information

Conditions

Ehlers-Danlos Syndrome Anesthesia, Local Cardiovascular Diseases Collagen Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

0.9% sodium chloride injection

Drug

All participants will be injected subcutaneously with a single 0.5ml dose

Other names: Saline

Lidocaine Injection 2%

Drug

All participants will be injected subcutaneously with a single 0.5ml dose

Other names: Xylocaine, lignocaine

Bupivacaine Injection 0.5%

Drug

All participants will be injected subcutaneously with a single 0.5ml dose

Other names: marcaine

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 Lidocaine at 30 min

Time frame: 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).
Delta Pain Scores Bupivacaine at 5 min

Time frame: 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).
Delta Pain Scores Bupivacaine at 30 min

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

University of Calgary

Registry information

Important dates

Study start: 2019
Primary completion: 2029
Study completion: 2029
First posted: Jul 29, 2019
Registry last updated: Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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