Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-30 @ 9:22 AM
Study NCT ID:
NCT04725357
Status:
UNKNOWN
Last Update Posted:
2021-01-26
First Post:
2021-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077239', 'term': 'Meloxicam'}], 'ancestors': [{'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-22', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-01-22', 'lastUpdatePostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Analgesic use', 'timeFrame': '14 days', 'description': 'Participants will be given a survey asking about number of pills taken'}, {'measure': 'Postoperative Pain Control', 'timeFrame': '14 days', 'description': 'Measured by the Numerical Rating Scale (NRS) pain score daily after surgery'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'The opioid epidemic continues to be a major concern, with orthopedic surgeons being among the top prescribers of opioids. Studies evaluating these practices found that opioids are overprescribed, even for common procedures. Patients undergoing arthroscopic labrum repair of the shoulder were found to have an average of 20 pills left over after surgery. Many strategies have been developed to tackle overprescribing and have found success, including no opioid protocols for carpal tunnel release. The purpose of this study is to examine if meloxicam alone provides similar patient reported outcomes to opioids following arthroscopic labrum repair of the shoulder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18\n* Scheduled for arthroscopic labrum repair of the shoulder\n\nExclusion Criteria:\n\n* History of opioid, acetaminophen, NSAID or local anesthetic allergy or intolerance, or contraindications to these medications.\n* Currently on long-term preoperative narcotics\n* Scheduled for revision arthroscopic repairs of the shoulder\n* Unable/unwilling to consent for enrollment\n* Unable to complete postoperative surveys\n* History of chronic pain syndromes (fibromyalgia, chronic diffuse MSK pain, etc)\n* Patients under the age of 18\n* Pregnant or breastfeeding women\n* Scheduled for concurrent procedures'}, 'identificationModule': {'nctId': 'NCT04725357', 'briefTitle': 'Does Meloxicam Provide as Much Pain Relief as Opioids After Shoulder Surgery?', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'A Randomized Comparison of Meloxicam to Opioids Following Arthroscopic Labrum Repairs of the Shoulder', 'orgStudyIdInfo': {'id': 'JHOR20D.1216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arthroscopic Labral Repair + postoperative Meloxicam', 'description': 'After surgery participants will receive a prescription of 20 pills of 15 mg Meloxicam', 'interventionNames': ['Drug: Meloxicam 15 mg', 'Procedure: Preoperative Interscalene Nerve Block', 'Procedure: arthroscopic labral repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arthroscopic Labral Repair without Meloxicam', 'description': 'After surgery participants will receive a prescription of 20 pills of 5/300 mg vicodin (hydrocodone/acetaminophen)', 'interventionNames': ['Procedure: Preoperative Interscalene Nerve Block', 'Procedure: arthroscopic labral repair']}], 'interventions': [{'name': 'Meloxicam 15 mg', 'type': 'DRUG', 'description': 'Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery', 'armGroupLabels': ['Arthroscopic Labral Repair + postoperative Meloxicam']}, {'name': 'Preoperative Interscalene Nerve Block', 'type': 'PROCEDURE', 'description': 'Preoperatively participants will standardly receive an interscalene nerve block', 'armGroupLabels': ['Arthroscopic Labral Repair + postoperative Meloxicam', 'Arthroscopic Labral Repair without Meloxicam']}, {'name': 'arthroscopic labral repair', 'type': 'PROCEDURE', 'description': 'participant will have their standard surgical procedure done', 'armGroupLabels': ['Arthroscopic Labral Repair + postoperative Meloxicam', 'Arthroscopic Labral Repair without Meloxicam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Orthopaedic Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}