Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-27 @ 4:06 PM
Study NCT ID:
NCT02823002
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2016-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Perception: Lidocaine Rate/Temp/Buffer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-05-20', 'releaseDate': '2025-05-05'}], 'estimatedResultsFirstSubmitDate': '2025-05-05'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000665', 'term': 'Ampholyte Mixtures'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D002021', 'term': 'Buffers'}], 'ancestors': [{'id': 'D019995', 'term': 'Laboratory Chemicals'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-14', 'studyFirstSubmitDate': '2016-06-27', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain on a Visual Analog Scale (VAS)', 'timeFrame': 'intraoperative', 'description': 'Subjects will rate the pain VAS score immediately after the needle is withdrawn. They will be asked to rate the pain of the injection of the solution. VAS pain scale is rated on a 10 cm scale with 0 cm being no pain and 10 cm being extremely painful.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study will collect data from multiple academic institutions. The primary objective for part A of this study is to determine the impact of anesthetic injection rate and temperature on pain perception during dermatologic procedures, and the objective for the part B of this study is to determine if buffering of the anesthetic solution alters pain perception.\n\nThis study is a pilot study designed to determine feasibility of these procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who are undergoing dermatologic procedures.\n* Subjects ages 18-89 year old.\n* The subjects have the willingness and the ability to understand and provide informed consent and communicate with the investigator.\n\nExclusion Criteria:\n\n* Subjects who are allergic to lidocaine.\n* History of bleeding tendency or coagulopathy.\n* Pregnant or lactating.\n* Active skin disease or skin infection in the treatment area.\n* Unable to understand the protocol or give informed consent.\n* Any other condition, in the professional opinion of the investigator, that would potentially affect response or participation in the clinical study, or would pose as an unacceptable risk to the subject.'}, 'identificationModule': {'nctId': 'NCT02823002', 'briefTitle': 'Pain Perception: Lidocaine Rate/Temp/Buffer', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'The Impact of Anesthetic Injection Rate, Temperature and Buffering on Pain Perception During Dermatologic Procedures: a Multicenter, Single-blinded Randomized Control Trial', 'orgStudyIdInfo': {'id': 'STU00202894'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow, Room Temperature', 'description': 'In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.', 'interventionNames': ['Procedure: Slow, Room Temperature Injection', 'Drug: Lidocaine', 'Drug: Buffer']}, {'type': 'EXPERIMENTAL', 'label': 'Rapid, Room Temperature', 'description': 'In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.', 'interventionNames': ['Procedure: Rapid, Room Temperature Injection', 'Drug: Lidocaine', 'Drug: Buffer']}, {'type': 'EXPERIMENTAL', 'label': 'Slow, Warmed', 'description': 'In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.', 'interventionNames': ['Procedure: Slow, Warm Temperature Injection', 'Drug: Lidocaine', 'Drug: Buffer']}, {'type': 'EXPERIMENTAL', 'label': 'Rapid, Warmed', 'description': 'In Part A, subject will be randomized to receive an injection of lidocaine that is slow at room temperature, rapid at room temperature, slow at warm temperature, or rapid at warm temperature.', 'interventionNames': ['Procedure: Rapid, Warm Temperature Injection', 'Drug: Lidocaine', 'Drug: Buffer']}, {'type': 'EXPERIMENTAL', 'label': 'Buffered', 'description': 'In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.', 'interventionNames': ['Procedure: Buffered Injection', 'Drug: Lidocaine', 'Drug: Buffer']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Buffered', 'description': 'In Part B, subject will be randomized to receive an injection of lidocaine that is buffered or non-buffered.', 'interventionNames': ['Procedure: Non-Buffered Injection', 'Drug: Lidocaine']}], 'interventions': [{'name': 'Slow, Room Temperature Injection', 'type': 'PROCEDURE', 'description': 'The room temperature local anesthetic agent will be administered by slow infiltration.', 'armGroupLabels': ['Slow, Room Temperature']}, {'name': 'Rapid, Room Temperature Injection', 'type': 'PROCEDURE', 'description': 'The room temperature local anesthetic agent will be administered by rapid infiltration.', 'armGroupLabels': ['Rapid, Room Temperature']}, {'name': 'Slow, Warm Temperature Injection', 'type': 'PROCEDURE', 'description': 'The warmed local anesthetic agent will be administered by slow infiltration.', 'armGroupLabels': ['Slow, Warmed']}, {'name': 'Rapid, Warm Temperature Injection', 'type': 'PROCEDURE', 'description': 'The warmed local anesthetic agent will be administered by rapid infiltration.', 'armGroupLabels': ['Rapid, Warmed']}, {'name': 'Buffered Injection', 'type': 'PROCEDURE', 'description': 'One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.', 'armGroupLabels': ['Buffered']}, {'name': 'Non-Buffered Injection', 'type': 'PROCEDURE', 'description': 'One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.', 'armGroupLabels': ['Non-Buffered']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)', 'armGroupLabels': ['Buffered', 'Non-Buffered', 'Rapid, Room Temperature', 'Rapid, Warmed', 'Slow, Room Temperature', 'Slow, Warmed']}, {'name': 'Buffer', 'type': 'DRUG', 'description': 'Sodium Bicarbonate', 'armGroupLabels': ['Buffered', 'Rapid, Room Temperature', 'Rapid, Warmed', 'Slow, Room Temperature', 'Slow, Warmed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Department of Dermatology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Murad Alam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery', 'investigatorFullName': 'Murad Alam', 'investigatorAffiliation': 'Northwestern University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-05-05', 'type': 'RELEASE'}, {'date': '2025-05-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University'}}}}