Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-02-28 @ 5:04 PM
Study NCT ID:
NCT02066818
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2013-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'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': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-18', 'studyFirstSubmitDate': '2013-11-18', 'studyFirstSubmitQcDate': '2014-02-18', 'lastUpdatePostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in VAS pain score over time', 'timeFrame': 'Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)', 'description': 'VAS measured at each of the 3 time points noted above.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['local anesthetic', 'incision and drainage', 'pain', 'cutaneous abscess'], 'conditions': ['Cutaneous Abscess', 'Pain']}, 'descriptionModule': {'briefSummary': 'Local anesthesia used for incision and drainage of abscesses is known to be painful.\n\nWe studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I\\&D) of skin abscesses.\n\nLocal injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I\\&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years\n* Skin abscess in need of incision and drainage (judged by treating physician)\n\nExclusion Criteria:\n\n* Allergy to lidocaine or tetracaine\n* Non-intact skin\n* Unable/unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02066818', 'briefTitle': 'Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ECUEM-Synera'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lidocaine Injection', 'description': 'Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess.', 'interventionNames': ['Drug: 1% lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine/tetracaine patch', 'description': 'Incision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess', 'interventionNames': ['Drug: Lidocaine/tetracaine patch']}], 'interventions': [{'name': 'Lidocaine/tetracaine patch', 'type': 'DRUG', 'otherNames': ['Synera patch'], 'armGroupLabels': ['Lidocaine/tetracaine patch']}, {'name': '1% lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine Injection']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christina L Bourne, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Christina L. Bourne', 'investigatorAffiliation': 'East Carolina University'}}}}