Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02779166
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2016-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Perioperative Celecoxib for Hip Arthroscopy
Sponsor:
Organization:
Raw JSON
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It is a continuous scale comprised of a 0-10 pain rating. 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'description': 'Monitored consumption of narcotic medications following surgery, measured in morphine equivalents', 'unitOfMeasure': 'morphine milligram equivalents', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Discharge Following Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': '50 patients received 400mg celecoxib prior to surgery\n\nCelecoxib: Received 400mg celecoxib prior to surgery'}, {'id': 'OG001', 'title': 'Placebo', 'description': '48 received placebo pill prior to surgery\n\nplacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '152.9', 'spread': '55.2', 'groupId': 'OG000'}, {'value': '172.9', 'spread': '57.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'time from OR to discharge, up to a maximum of 6 hours postoperatively', 'description': 'Total time to discharge from OR close following surgery, measured in minutes', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': '50 patients received 400mg celecoxib prior to surgery\n\nCelecoxib: Received 400mg celecoxib prior to surgery'}, {'id': 'FG001', 'title': 'Placebo', 'description': '48 received placebo pill prior to surgery\n\nplacebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Received 400mg celecoxib prior to surgery\n\nCelecoxib: Received 400mg celecoxib prior to surgery'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Received placebo pill prior to surgery\n\nplacebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.2', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '35.0', 'spread': '11.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2016-05-13', 'resultsFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-23', 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Score for Pain (VAS) in the Immediate Post Operative Period', 'timeFrame': 'Pre operative on day of surgery, immediately following OR close, 1 hr post operatively, 2 hrs post operatively', 'description': 'The pain VAS is a uni dimensional measure of pain intensity. It is a continuous scale comprised of a 0-10 pain rating. A score of 0 indicates no pain while a score of 10 would indicate extreme pain.'}, {'measure': 'Total Narcotic Consumption in the Post Anesthesia Care Unit (PACU)', 'timeFrame': 'duration of PACU stay,immediate post op period up to a maximum of 4 hours postoperatively', 'description': 'Monitored consumption of narcotic medications following surgery, measured in morphine equivalents'}, {'measure': 'Time to Discharge Following Surgery', 'timeFrame': 'time from OR to discharge, up to a maximum of 6 hours postoperatively', 'description': 'Total time to discharge from OR close following surgery, measured in minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hip arthroscopy'], 'conditions': ['Hip Labral Tears']}, 'descriptionModule': {'briefSummary': 'Celecoxib is commonly used for perioperative pain control for certain orthopaedic procedures. It has been shown to be successful in assisting in pain control for knee arthroscopy. It has not previously been studied in hip arthroscopy. This is a double blinded randomized controlled trial to determine the efficacy of celecoxib in perioperative pain control for hip arthroscopy.', 'detailedDescription': 'This study examines the efficacy of perioperative dose of celecoxib in pain management after hip arthroscopy. Perioperative administration of celecoxib has been shown to improve pain control after knee arthroscopy, but this has not yet been studied in the hip. In this study, patients are randomized to receive either 400mg celecoxib or placebo 1 hour prior to undergoing hip arthroscopy surgery. Postoperatively, patients are monitored for pain on the VAS scale, narcotic use, and meeting discharge criteria. The study will enroll 100 patients. Patients are approached for informed consent on the day of surgery. Pain scores, narcotic use, and time to discharge in the celecoxib group are compared to the placebo group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.\n\nExclusion Criteria:\n\n* Pregnant women and any patient under the age of 18 years.'}, 'identificationModule': {'nctId': 'NCT02779166', 'acronym': 'Celecoxib', 'briefTitle': 'Evaluation of Perioperative Celecoxib for Hip Arthroscopy', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Evaluation of Perioperative Celecoxib for Hip Arthroscopy', 'orgStudyIdInfo': {'id': 'STU00067550'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Received 400mg celecoxib prior to surgery', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Received placebo pill prior to surgery', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'description': 'Received 400mg celecoxib prior to surgery', 'armGroupLabels': ['Intervention']}, {'name': 'placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael Terry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Michael Terry', 'investigatorAffiliation': 'Northwestern University'}}}}