Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02029235
Status:
TERMINATED
Last Update Posted:
2018-12-13
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-operative Analgesia in Elective, Soft-tissue Hand Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D045888', 'term': 'Ganglion Cysts'}, {'id': 'D052582', 'term': 'Trigger Finger Disorder'}, {'id': 'D053684', 'term': 'De Quervain Disease'}], 'ancestors': [{'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D053682', 'term': 'Tendon Entrapment'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}], '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'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'apayatakes@pennstatehealth.psu.edu', 'phone': '717-531-4805', 'title': 'Alexander Payatakes, MD', 'organization': 'Penn State Health Milton S. Hershey Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to slower than anticipated recruitment.'}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'Definition consistent with those listed on clinicaltrials.gov website.\n\nAdverse event collection occurred at postop day 7 phone call, as well as first follow-up clinic-visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Acetaminophen/Ibuprofen (AIBU) Group', 'description': 'Acetaminophen 500 mg and Ibuprofen 400 mg\n\nAcetaminophen/Ibuprofen: Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 1, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Acetaminophen/Hydrocodone (AH) Group', 'description': 'Acetaminophen 325 mg and Hydrocodone 5 mg\n\nAcetaminophen/Hydrocodone: Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 7, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Drowsiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itchiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy Comparison of Pain Intensity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen/Ibuprofen (AIBU) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.'}, {'id': 'OG001', 'title': 'Acetaminophen/Hydrocodone (AH) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.'}], 'classes': [{'title': 'Daily average pain intensity level on PostOp Day 1', 'categories': [{'measurements': [{'value': '22.17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '24.07', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}, {'title': 'Daily average pain intensity level on PostOp Day 2', 'categories': [{'measurements': [{'value': '22.22', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '93'}, {'value': '30.16', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '95'}]}]}, {'title': 'Daily average pain intensity level on PostOp Day 3', 'categories': [{'measurements': [{'value': '15.67', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '75'}, {'value': '22.11', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '90'}]}]}, {'title': 'Daily average pain intensity levelon PostOp Day 4', 'categories': [{'measurements': [{'value': '13.17', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '55'}, {'value': '18.53', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '90'}]}]}, {'title': 'Daily average pain intensity level on PostOp Day 5', 'categories': [{'measurements': [{'value': '14.03', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '67'}, {'value': '16.61', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '90'}]}]}, {'title': 'Daily average pain intensity level on PostOp Day 6', 'categories': [{'measurements': [{'value': '13.44', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '50'}, {'value': '13.58', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '73'}]}]}, {'title': 'Daily average pain intensity level on PostOp Day 7', 'categories': [{'measurements': [{'value': '12.67', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '65'}, {'value': '13.00', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference between groups\n\nPower analysis: A sample size of 16 in each group had an 80% power to detect a difference in means of 10 mm.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 week post-operatively', 'description': "Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours.\n\nThe daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome.\n\nThe daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test.", 'unitOfMeasure': 'score on a scale (0-100, higher = worse)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy Comparison of Pain Relief', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetaminophen/Ibuprofen (AIBU) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.'}, {'id': 'OG001', 'title': 'Acetaminophen/Hydrocodone (AH) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.'}], 'classes': [{'title': 'Daily average pain relief on PostOp Day 1', 'categories': [{'measurements': [{'value': '1.84', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.53', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Daily average pain relief on PostOp Day 2', 'categories': [{'measurements': [{'value': '2.27', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Daily average pain relief on PostOp Day 3', 'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Daily average pain relief on PostOp Day 4', 'categories': [{'measurements': [{'value': '2.91', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.46', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Daily average pain relief on PostOp Day 5', 'categories': [{'measurements': [{'value': '2.88', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.54', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Daily average pain relief on PostOp Day 6', 'categories': [{'measurements': [{'value': '2.87', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.84', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Daily average pain relief on PostOp Day 7', 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.88', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Null hypothesis: No difference between groups', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 week postoperatively', 'description': 'Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.\n\nDaily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.\n\nThe daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models', 'unitOfMeasure': 'score on a scale (0-3, higher = better)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetaminophen/Ibuprofen (AIBU) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.'}, {'id': 'FG001', 'title': 'Acetaminophen/Hydrocodone (AH) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Non-compliance with study meds or diary', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited during clinic visits to discuss elective, soft tissue hand surgery at a single academic medical center between February 2015 and October 2017. The first participant was enrolled in February 2015, and the last participant was enrolled in October 2017.', 'preAssignmentDetails': 'Seven patients withdrew or were excluded prior to randomization due to cancellation of surgery (3), refusal to participate (3), and a newly diagnosed gastrointestinal ulcer (exclusion criterion) prior to surgery (1).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetaminophen/Ibuprofen (AIBU) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 500 mg / Ibuprofen 400 mg every 4 hours, as needed, for one week or until essentially pain-free.'}, {'id': 'BG001', 'title': 'Acetaminophen/Hydrocodone (AH) Group', 'description': 'Postoperatively, subjects were given:\n\nAcetaminophen 325 mg / Hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '86'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '75'}, {'value': '53', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Patient Health Questionnaire (PHQ-9)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.83', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '12'}, {'value': '2.63', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '14'}, {'value': '2.23', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '14'}]}]}], 'paramType': 'MEAN', 'description': 'The Patient Health Questionnaire (PHQ-0) objectifies degree of depression severity.\n\nIt provides a total score on a scale of 0 - 27, with higher being worse (i.e. more severe depression).', 'unitOfMeasure': 'units on a scale (total score)', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Subjects randomized into study groups and completing protocol'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-11-10', 'size': 464548, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-10-21T21:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'whyStopped': 'Early termination due to slower than anticipated recruitment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-12', 'studyFirstSubmitDate': '2014-01-03', 'resultsFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-12', 'studyFirstPostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy Comparison of Pain Intensity Level', 'timeFrame': '1 week post-operatively', 'description': "Subjects asked to fill out a patient diary recording their pain intensity level (on 100mm Visual Analog Scale) prior to taking study medication every 4 hours.\n\nThe daily average pain intensity levels are reported as a score on a scale of 0-100, with higher score meaning worse outcome.\n\nThe daily average pain levels were assessed daily for 1 week post-operatively, then compared between the 2 groups using a two-group Student's t-test."}], 'secondaryOutcomes': [{'measure': 'Efficacy Comparison of Pain Relief', 'timeFrame': '1 week postoperatively', 'description': 'Subjects asked to fill out a patient diary recording their pain relief (on a Likert scale) one hour after taking study medication every 4 hours.\n\nDaily average pain relief scores are reported as a score on a scale of 0-3, with higher score meaning better outcome.\n\nThe daily average pain relief scores were assessed daily for 1 week post-operatively, then compared using generalized linear mixed-effects models'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adult', 'soft-tissue hand surgery'], 'conditions': ['Carpal Tunnel', 'Ganglion Cyst', 'Trigger Finger', 'De Quervain Disease']}, 'referencesModule': {'references': [{'pmid': '22410178', 'type': 'BACKGROUND', 'citation': 'Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.'}, {'pmid': '17227967', 'type': 'BACKGROUND', 'citation': 'Kuehn BM. Opioid prescriptions soar: increase in legitimate use as well as abuse. JAMA. 2007 Jan 17;297(3):249-51. doi: 10.1001/jama.297.3.249. No abstract available.'}, {'pmid': '20559200', 'type': 'BACKGROUND', 'citation': 'Centers for Disease Control and Prevention (CDC). Emergency department visits involving nonmedical use of selected prescription drugs - United States, 2004-2008. MMWR Morb Mortal Wkly Rep. 2010 Jun 18;59(23):705-9.'}, {'pmid': '22713999', 'type': 'BACKGROUND', 'citation': 'Mitchell A, McCrea P, Inglis K, Porter G. A randomized, controlled trial comparing acetaminophen plus ibuprofen versus acetaminophen plus codeine plus caffeine (Tylenol 3) after outpatient breast surgery. Ann Surg Oncol. 2012 Nov;19(12):3792-800. doi: 10.1245/s10434-012-2447-7. Epub 2012 Jun 20.'}, {'pmid': '21156974', 'type': 'BACKGROUND', 'citation': 'White PF, Tang J, Wender RH, Zhao M, Time M, Zaentz A, Yumul R, Sloninsky A, Naruse R, Kariger R, Webb T, Fermelia DE, Tsushima GK. The effects of oral ibuprofen and celecoxib in preventing pain, improving recovery outcomes and patient satisfaction after ambulatory surgery. Anesth Analg. 2011 Feb;112(2):323-9. doi: 10.1213/ANE.0b013e3182025a8a. Epub 2010 Dec 14.'}, {'pmid': '9597202', 'type': 'BACKGROUND', 'citation': 'Beauregard L, Pomp A, Choiniere M. Severity and impact of pain after day-surgery. Can J Anaesth. 1998 Apr;45(4):304-11. doi: 10.1007/BF03012019.'}, {'pmid': '7717561', 'type': 'BACKGROUND', 'citation': 'Dexter F, Chestnut DH. Analysis of statistical tests to compare visual analog scale measurements among groups. Anesthesiology. 1995 Apr;82(4):896-902. doi: 10.1097/00000542-199504000-00012.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out which combination of pain medications following surgery work the best and result in the fewest side effects.', 'detailedDescription': 'This is a prospective, randomized, double-blind study comparing the efficacy of acetaminophen/hydrocodone (AH) to acetaminophen/ibuprofen (AIBU) in providing adequate post-operative pain relief in elective, soft tissue hand surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18\n* Male or Female (non-pregnant)\n* Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release)\n* Subjects are capable of giving informed consent\n\nExclusion Criteria:\n\n* Allergy to study medication\n* Any pre-existing pain condition requiring analgesia\n* Fibromyalgia\n* Recent upper gastrointestinal bleeding\n* Coagulopathy (primary or medication-related)\n* Renal impairment\n* Liver disease\n* Pregnancy\n* Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization'}, 'identificationModule': {'nctId': 'NCT02029235', 'briefTitle': 'Post-operative Analgesia in Elective, Soft-tissue Hand Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Post-operative Analgesia in Elective, Soft-tissue Hand Surgery: A Randomized, Double Blind Comparison of Acetaminophen/Ibuprofen Versus Acetaminophen/Hydrocodone', 'orgStudyIdInfo': {'id': 'IRB - 00076'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen/Ibuprofen (AIBU) Group', 'description': 'Acetaminophen 500 mg and Ibuprofen 400 mg', 'interventionNames': ['Drug: Acetaminophen/Ibuprofen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetaminophen/Hydrocodone (AH) Group', 'description': 'Acetaminophen 325 mg and Hydrocodone 5 mg', 'interventionNames': ['Drug: Acetaminophen/Hydrocodone']}], 'interventions': [{'name': 'Acetaminophen/Ibuprofen', 'type': 'DRUG', 'otherNames': ['Acetaminophen/Tylenol', 'Ibuprofen/Advil/Motrin'], 'description': 'Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free', 'armGroupLabels': ['Acetaminophen/Ibuprofen (AIBU) Group']}, {'name': 'Acetaminophen/Hydrocodone', 'type': 'DRUG', 'otherNames': ['Norco'], 'description': 'Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free', 'armGroupLabels': ['Acetaminophen/Hydrocodone (AH) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Alexander Payatakes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexander Payatakes, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator / Sponsor', 'investigatorFullName': 'Alexander Payatakes, M.D.', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}