Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04036305
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-14
First Post:
2019-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004535', 'term': 'Ehlers-Danlos Syndrome'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA samples from saliva will be collected in a subset of individuals for possible future analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 230}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2019-07-25', 'studyFirstSubmitQcDate': '2019-07-25', 'lastUpdatePostDateStruct': {'date': '2025-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta Pain Scores Lidocaine at 5 min', 'timeFrame': '5 minutes post-injection', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Delta Pain Scores Lidocaine at 30 min', 'timeFrame': '30 min', 'description': '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).'}, {'measure': 'Delta Pain Scores Bupivacaine at 5 min', 'timeFrame': '5 min', 'description': '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).'}, {'measure': 'Delta Pain Scores Bupivacaine at 30 min', 'timeFrame': '30 min', 'description': '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).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ehlers-Danlos Syndrome', 'Local Anesthesia Resistance'], 'conditions': ['Ehlers-Danlos Syndrome', 'Anesthesia, Local']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'EDS patients and non-EDS participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* EDS patients, clinically diagnosed hypermobile EDS based on 2017 criteria\n* EDS patients with genetically proven non-hypermobile EDS\n* Healthy participants, no EDS\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Known allergy to Lidocaine or Bupivacaine\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04036305', 'briefTitle': 'Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers', 'orgStudyIdInfo': {'id': '190957'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EDS Patients', 'description': 'Patients meeting the diagnostic criteria (2017) for Ehlers-Danlos Syndrome', 'interventionNames': ['Drug: 0.9% Sodium Chloride Injection', 'Drug: Lidocaine Injection 2%', 'Drug: Bupivacaine Injection 0.5%']}, {'label': 'Healthy Volunteers', 'description': 'Healthy control volunteers who do not meet the criteria for Ehlers-Danlos Syndrome', 'interventionNames': ['Drug: 0.9% Sodium Chloride Injection', 'Drug: Lidocaine Injection 2%', 'Drug: Bupivacaine Injection 0.5%']}], 'interventions': [{'name': '0.9% Sodium Chloride Injection', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'All participants will be injected subcutaneously with a single 0.5ml dose', 'armGroupLabels': ['EDS Patients', 'Healthy Volunteers']}, {'name': 'Lidocaine Injection 2%', 'type': 'DRUG', 'otherNames': ['Xylocaine', 'lignocaine'], 'description': 'All participants will be injected subcutaneously with a single 0.5ml dose', 'armGroupLabels': ['EDS Patients', 'Healthy Volunteers']}, {'name': 'Bupivacaine Injection 0.5%', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'All participants will be injected subcutaneously with a single 0.5ml dose', 'armGroupLabels': ['EDS Patients', 'Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Satish R Raj, MD MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Calgary', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Associate Professor of Medicine', 'investigatorFullName': 'Satish R. Raj', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}