Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT04814433
Status:
TERMINATED
Last Update Posted:
2024-06-26
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D015119', 'term': 'Aminocaproic Acid'}, {'id': 'C513462', 'term': 'recombinant human thrombin'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000614', 'term': 'Aminocaproates'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Thomas.Calahan@nyulangone.org', 'phone': '929-455-5826', 'title': 'Thomas Calahan', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Topical Lidocaine and Bupivacaine Alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Postoperative Pain Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine and Bupivacaine Alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine'}, {'id': 'OG001', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin'}, {'id': 'OG002', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid'}, {'id': 'OG003', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '8'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '7'}, {'value': '4.7', 'groupId': 'OG003', 'lowerLimit': '3', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 preoperative , Day 14 postoperative', 'description': 'Measured by self-reported level of pain recorded in a daily pain diary made by the researchers from the day of the surgery until post-operative day 14. The levels of pain are scored in the following manner: 1-2 no pain, 3-4 mild pain, 5-6 moderate pain, 7-8 severe pain, 9-10 worst pain imaginable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Amount of Opioid Pain Medication Required Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine and Bupivacaine Alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine'}, {'id': 'OG001', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin'}, {'id': 'OG002', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid'}, {'id': 'OG003', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '9'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '10'}, {'value': '6', 'groupId': 'OG003', 'lowerLimit': '2', 'upperLimit': '9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 postoperative to Day 14 postoperative', 'description': 'Measured by self-reported number of pain pills taken postoperatively until post-operative day 14.', 'unitOfMeasure': 'Pills', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Time in Post Anesthesia Care Unit (PACU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Lidocaine and Bupivacaine Alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine'}, {'id': 'OG001', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin'}, {'id': 'OG002', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid'}, {'id': 'OG003', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid'}], 'timeFrame': 'From Day 1 postoperative until discharge from PACU (up to 1 day)', 'reportingStatus': 'POSTED', 'populationDescription': 'The outcome measure "total time in PACU" was not able to be assessed because there was no consistent measurement taken during the study by PACU nurses of this time period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Lidocaine and Bupivacaine Alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine'}, {'id': 'FG001', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin'}, {'id': 'FG002', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid'}, {'id': 'FG003', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Survey not returned', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Lidocaine and Bupivacaine Alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine'}, {'id': 'BG001', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin'}, {'id': 'BG002', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Tranexamic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid'}, {'id': 'BG003', 'title': 'Topical Lidocaine and Bupivacaine With Thrombin and Aminocaproic Acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '57', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '61', 'spread': '2.8', 'groupId': 'BG002'}, {'value': '53', 'spread': '3.4', 'groupId': 'BG003'}, {'value': '56', 'spread': '3.4', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-25', 'size': 313005, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-31T13:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'whyStopped': 'Both lack of enrollment as well as study staff turnover', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-31', 'studyFirstSubmitDate': '2021-03-22', 'resultsFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2021-03-22', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-31', 'studyFirstPostDateStruct': {'date': '2021-03-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Postoperative Pain Control', 'timeFrame': 'Day 1 preoperative , Day 14 postoperative', 'description': 'Measured by self-reported level of pain recorded in a daily pain diary made by the researchers from the day of the surgery until post-operative day 14. The levels of pain are scored in the following manner: 1-2 no pain, 3-4 mild pain, 5-6 moderate pain, 7-8 severe pain, 9-10 worst pain imaginable.'}], 'secondaryOutcomes': [{'measure': 'Amount of Opioid Pain Medication Required Postoperatively', 'timeFrame': 'From Day 1 postoperative to Day 14 postoperative', 'description': 'Measured by self-reported number of pain pills taken postoperatively until post-operative day 14.'}, {'measure': 'Total Time in Post Anesthesia Care Unit (PACU)', 'timeFrame': 'From Day 1 postoperative until discharge from PACU (up to 1 day)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Pain Medication']}, 'descriptionModule': {'briefSummary': 'This study is a prospective randomized trial examining the effect of topically combined antifibrinolytics (Tranexamic acid) with local anesthetics in all electively created surgical wound beds in hand surgery to provide long term pain relief and decrease the use of postoperative narcotics.', 'detailedDescription': 'The aim of the study is to provide long term pain relief and decrease the use of postoperative narcotics. All treatments are applied topically to the surgical bed prior to closure of the skin. Each of the drugs used in this study are Food and Drug Administration (FDA) approved and routinely used for pain relief. However, the route of administration of the drugs and addition of tranexamic acid or aminocaproic acid is considered off-label (outside of the FDA-approved indications) and therefore investigational.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 or older\n* Any patient undergoing elective hand surgery\n\nExclusion Criteria:\n\n* Any patient with a traumatic open wound (only surgically created wounds will be included)\n* History of chronic pain\n* History of narcotic addiction\n* History of recreational drug dependency\n* History of psychiatric pathology\n* Allergy to local anesthetics, recombinant human thrombin or tranexamic acid\n* Any patient receiving a supra/infraclavicular block for anesthesia'}, 'identificationModule': {'nctId': 'NCT04814433', 'briefTitle': 'Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'A Randomized, Single-Blinded, Placebo-Controlled Study Evaluating Postoperative Non-Opioid Pain Management Utilizing Local Anesthetics Coupled With Modulated Coagulation', 'orgStudyIdInfo': {'id': '20-01420'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical lidocaine and bupivacaine alone', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine', 'interventionNames': ['Drug: Lidocaine Hydrochloride with Epinephrine', 'Drug: Bupivacaine Hydrochloride with Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Topical lidocaine and bupivacaine with thrombin', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin', 'interventionNames': ['Drug: Recombinant Human Thrombin', 'Drug: Lidocaine Hydrochloride with Epinephrine', 'Drug: Bupivacaine Hydrochloride with Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Topical lidocaine and bupivacaine with thrombin and tranexamic acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 500 mg of tranexamic acid', 'interventionNames': ['Drug: Tranexamic acid', 'Drug: Recombinant Human Thrombin', 'Drug: Lidocaine Hydrochloride with Epinephrine', 'Drug: Bupivacaine Hydrochloride with Epinephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Topical lidocaine and bupivacaine with thrombin and aminocaproic acid', 'description': 'In this treatment group, each solution will include 5 ml of 1% lidocaine, 5 ml of 0.25% bupivacaine, 10000 units of thrombin, and 1000 mg of aminocaproic acid', 'interventionNames': ['Drug: Tranexamic acid', 'Drug: Aminocaproic acid', 'Drug: Recombinant Human Thrombin', 'Drug: Lidocaine Hydrochloride with Epinephrine', 'Drug: Bupivacaine Hydrochloride with Epinephrine']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'description': 'FDA-approved usage for intravenous tranexamic acid (TXA) is for heavy menstrual bleeding and short-term prevention in patients with hemophilia.\n\nTotal dose of 500 mg (20 mL) total will be given.', 'armGroupLabels': ['Topical lidocaine and bupivacaine with thrombin and aminocaproic acid', 'Topical lidocaine and bupivacaine with thrombin and tranexamic acid']}, {'name': 'Aminocaproic acid', 'type': 'DRUG', 'description': 'FDA notes that aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. Aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The fibrinolysis-inhibitory effects of aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.\n\nTotal of 1000 mg total will be given.', 'armGroupLabels': ['Topical lidocaine and bupivacaine with thrombin and aminocaproic acid']}, {'name': 'Recombinant Human Thrombin', 'type': 'DRUG', 'description': 'Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient.\n\nRecombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL.\n\nFor topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given', 'armGroupLabels': ['Topical lidocaine and bupivacaine with thrombin', 'Topical lidocaine and bupivacaine with thrombin and aminocaproic acid', 'Topical lidocaine and bupivacaine with thrombin and tranexamic acid']}, {'name': 'Lidocaine Hydrochloride with Epinephrine', 'type': 'DRUG', 'description': 'Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.\n\nEach mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.\n\nTotal of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given', 'armGroupLabels': ['Topical lidocaine and bupivacaine alone', 'Topical lidocaine and bupivacaine with thrombin', 'Topical lidocaine and bupivacaine with thrombin and aminocaproic acid', 'Topical lidocaine and bupivacaine with thrombin and tranexamic acid']}, {'name': 'Bupivacaine Hydrochloride with Epinephrine', 'type': 'DRUG', 'description': 'Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.\n\nEach mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.\n\nTotal of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given', 'armGroupLabels': ['Topical lidocaine and bupivacaine alone', 'Topical lidocaine and bupivacaine with thrombin', 'Topical lidocaine and bupivacaine with thrombin and aminocaproic acid', 'Topical lidocaine and bupivacaine with thrombin and tranexamic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David Chiu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)', 'accessCriteria': 'The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to Thomas.Calahan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}