Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT04278703
Status:
UNKNOWN
Last Update Posted:
2020-02-20
First Post:
2020-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioids Following ACL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': '14 days post-operative', 'description': 'Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.\n\nExclusion Criteria:\n\n* Concomitant procedure other than meniscectomy or meniscal repair.\n* ACL revision\n* History of chronic pre-operative opioid use\n* History of substance abuse\n* Workmen's compensation claims\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT04278703', 'briefTitle': 'Opioids Following ACL', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'The Utilization of Opioid Medication Following ACL Reconstruction', 'orgStudyIdInfo': {'id': '2020 TJ 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '15 opioid tablets perscribed', 'description': 'For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '25 opioid tablets perscribed', 'description': 'For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '35 opioid tablets perscribed', 'description': 'For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain', 'interventionNames': ['Drug: oxycodone']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Patients will be given a prescription for 15 opioid tablets for post-operative pain', 'armGroupLabels': ['15 opioid tablets perscribed']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Patients will be given a prescription for 25 opioid tablets for post-operative pain', 'armGroupLabels': ['25 opioid tablets perscribed']}, {'name': 'oxycodone', 'type': 'DRUG', 'description': 'Patients will be given a prescription for 35 opioid tablets for post-operative pain', 'armGroupLabels': ['35 opioid tablets perscribed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08234', 'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rothman Orthopaedics at Egg Harbor Township', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}