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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04036305
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2019
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University Medical Center

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.

Condition or disease Intervention/treatment
Ehlers-Danlos Syndrome Anesthesia, Local Drug: 0.9% Sodium Chloride Injection Drug: Lidocaine Injection 2% Drug: Bupivacaine Injection 0.5%

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.

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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Actual Study Start Date : July 26, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
EDS Patients
Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome
Drug: 0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
Other Name: Saline

Drug: Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
Other Names:
  • Xylocaine
  • lignocaine

Drug: Bupivacaine Injection 0.5%
All participants will be injected subcutaneously with a single 0.5ml dose
Other Name: marcaine

Healthy Volunteers
Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome
Drug: 0.9% Sodium Chloride Injection
All participants will be injected subcutaneously with a single 0.5ml dose
Other Name: Saline

Drug: Lidocaine Injection 2%
All participants will be injected subcutaneously with a single 0.5ml dose
Other Names:
  • Xylocaine
  • lignocaine

Drug: Bupivacaine Injection 0.5%
All participants will be injected subcutaneously with a single 0.5ml dose
Other Name: marcaine




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).

  2. 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).

  3. 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).


Biospecimen Retention:   Samples With DNA
DNA samples from saliva will be collected in a subset of individuals for possible future analysis.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
EDS patients and non-EDS participants
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036305


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
University of Calgary
Investigators
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Principal Investigator: Satish R Raj, MD MSCI Vanderbilt University Medical Center
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Responsible Party: Satish R. Raj, Adjunct Associate Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT04036305    
Other Study ID Numbers: 190957
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Satish R. Raj, Vanderbilt University Medical Center:
Ehlers-Danlos Syndrome
Local Anesthesia Resistance
Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action