Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 9:34 PM
Study NCT ID:
NCT01330134
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2011-04-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Two Lidocaine Administration Techniques
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jkress@medicine.bsd.uchicago.edu', 'phone': '773-702-1000', 'title': 'John P. Kress, MD', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection', 'description': 'lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection', 'otherNumAtRisk': 244, 'deathsNumAtRisk': 244, 'otherNumAffected': 0, 'seriousNumAtRisk': 244, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lidocaine Subcutaneous Injection Alone', 'description': 'lidocaine: 1% lidocaine subcutaneous injection alone', 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 0, 'seriousNumAtRisk': 237, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Assessment: Overall', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection', 'description': 'lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.'}, {'id': 'OG001', 'title': 'Lidocaine Subcutaneous Injection Alone', 'description': 'lidocaine: 1% lidocaine subcutaneous injection alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '22.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post procedure (day 1)', 'description': 'Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Assessment: Lidocaine Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection', 'description': 'lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.'}, {'id': 'OG001', 'title': 'Lidocaine Subcutaneous Injection Alone', 'description': 'lidocaine: 1% lidocaine subcutaneous injection alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '23.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post procedure (day 1)', 'description': 'visual analog scale (VAS) 0= no pain to 100 = worse pain possible', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Assessment: During Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection', 'description': 'lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.'}, {'id': 'OG001', 'title': 'Lidocaine Subcutaneous Injection Alone', 'description': 'lidocaine: 1% lidocaine subcutaneous injection alone.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '24.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'post procedure (day 1)', 'description': 'visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection', 'description': 'lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.'}, {'id': 'FG001', 'title': 'Lidocaine Subcutaneous Injection Alone', 'description': 'lidocaine: 1% lidocaine subcutaneous injection alone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '244'}, {'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '244', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lidocaine Onto Skin Prior to Lidocaine Subcutaneous Injection', 'description': 'lidocaine: 2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection.'}, {'id': 'BG001', 'title': 'Lidocaine Subcutaneous Injection Alone', 'description': 'lidocaine: 1% lidocaine subcutaneous injection alone.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'groupId': 'BG000', 'lowerLimit': '46.4', 'upperLimit': '68.6'}, {'value': '56.8', 'groupId': 'BG001', 'lowerLimit': '44.8', 'upperLimit': '65.4'}, {'value': '57.4', 'groupId': 'BG002', 'lowerLimit': '45.2', 'upperLimit': '67.4'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'white, nonhispanic', 'categories': [{'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}, {'title': 'white, hispanic', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'african american', 'categories': [{'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}]}, {'title': 'asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 481}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-27', 'studyFirstSubmitDate': '2011-04-04', 'resultsFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-30', 'studyFirstPostDateStruct': {'date': '2011-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Assessment: Overall', 'timeFrame': 'post procedure (day 1)', 'description': 'Visual analog scale (VAS). This is a standardized analog scale with scores from 0-100. It measures level of pain with 0 meaning no pain and 100 meaning the most extreme level of pain. Higher values refer to a worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Pain Assessment: Lidocaine Injection', 'timeFrame': 'post procedure (day 1)', 'description': 'visual analog scale (VAS) 0= no pain to 100 = worse pain possible'}, {'measure': 'Pain Assessment: During Procedure', 'timeFrame': 'post procedure (day 1)', 'description': 'visual analog scale (VAS) 0 = no pain to 100 = worse pain possible Rather, this is a pain assessment during the actual procedure rather than during the pre-procedure lidocaine injection.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['procedural'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '29698720', 'type': 'DERIVED', 'citation': 'Patel BK, Wendlandt BN, Wolfe KS, Patel SB, Doman ER, Pohlman AS, Hall JB, Kress JP. Comparison of Two Lidocaine Administration Techniques on Perceived Pain From Bedside Procedures: A Randomized Clinical Trial. Chest. 2018 Oct;154(4):773-780. doi: 10.1016/j.chest.2018.04.018. Epub 2018 Apr 24.'}]}, 'descriptionModule': {'briefSummary': 'The objective of our study is to determine if technique of lidocaine administration can decrease pain perception.\n\nHypothesis: There will be a significant difference in pain perception between patients who are given lidocaine on the skin surface prior to subcutaneous injection and patients who are given only subcutaneous injection by standard approach.', 'detailedDescription': 'This is a single center prospective, randomized, blinded study assessing pain perception following 2 different lidocaine administration techniques in subjects who have planned medical procedures requiring local injection of lidocaine. Subjects will be approached and consented to participate in the study. They will be interviewed after the scheduled medical procedure to assess their pain using validated pain scores. An investigator who is not present for the procedure and blinded to the randomization will gather data regarding perceptions of pain from the entire procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients refered to the University of Chicago Medical Centers Procedure Service for a planned medical procedure requiring local injection of lidocaine.\n\nExclusion Criteria:\n\n* Patient who lack decisional capacity to consent\n* Patients who lack the ability to answer questions in english using pain scales'}, 'identificationModule': {'nctId': 'NCT01330134', 'briefTitle': 'Comparison of Two Lidocaine Administration Techniques', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Comparison of Two Lidocaine Administration Techniques', 'orgStudyIdInfo': {'id': '10-621A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine onto skin prior to lidocaine subcutaneous injection', 'description': '1-2ml of 1% lidocaine dripped onto the surface of the skin immediately prior to subcutaneous injection of 1% lidocaine.', 'interventionNames': ['Drug: lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lidocaine subcutaneous injection alone', 'description': '1% lidocaine subcutaneous injection alone by standard approach', 'interventionNames': ['Drug: lidocaine']}], 'interventions': [{'name': 'lidocaine', 'type': 'DRUG', 'description': '2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection', 'armGroupLabels': ['lidocaine onto skin prior to lidocaine subcutaneous injection']}, {'name': 'lidocaine', 'type': 'DRUG', 'description': '1% lidocaine subcutaneous injection alone', 'armGroupLabels': ['lidocaine subcutaneous injection alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'John P Kress, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}