Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-01 @ 3:26 AM
Study NCT ID:
NCT03818932
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2019-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-02-16', 'mcpReleaseN': 2, 'releaseDate': '2022-01-27'}, {'resetDate': '2024-04-01', 'releaseDate': '2024-03-04'}], 'estimatedResultsFirstSubmitDate': '2022-01-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'C514822', 'term': 'oxycodone-acetaminophen'}, {'id': 'D020910', 'term': 'Ketorolac'}, {'id': 'D020911', 'term': 'Ketorolac Tromethamine'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D003975', 'term': 'Diazepam'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D001570', 'term': 'Benzodiazepinones'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2019-01-23', 'studyFirstSubmitQcDate': '2019-01-24', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Levels', 'timeFrame': '10 days post-operatively', 'description': 'Patients record pain levels every 3 hours using Visual analog scales for 10 days post-operatively. Average daily pain was calculated for each patient. Higher values portend worse control.'}, {'measure': 'Patient-Reported Outcomes Measurement Information System', 'timeFrame': '10 days post-operatively', 'description': 'Patient-Reported Outcomes Measurement Information System Physical Interference (PROMIS PI) once every night for 10 days post-operatively. Average PROMIS PI values calculated nightly. A higher score indicates more pain interference.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Cruciate Ligament Injury']}, 'descriptionModule': {'briefSummary': 'This is a randomized, single blinded, standard of care controlled clinical trial. This project aims to compare postoperative pain control in patients in two treatment arms of anterior cruciate ligament reconstruction: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen', 'detailedDescription': "Study Design: This is a randomized, single blinded, standard of care-controlled clinical trial. All adult patients over eighteen desiring anterior cruciate ligament reconstruction will be eligible. Nonnarcotic postoperative pain control regimen described below were chosen based on previous studies in fracture care and joint arthroplasty.\n\nPatients will be consented and recruited. Once participation has been determined and consent obtained, the names of participating patients will be provided to the research pharmacy. Patients will be randomized with a computer-generated table in 2 patient blocks by the research pharmacy. Patients postoperative analgesia will be divided into one of the following 2 treatment arms: 1) A novel nonopioid pain protocol or 2) traditional narcotic pain analgesia\n\nPrimary endpoints is reduction in pain as measured by Visual Analogue Scale and Patient-Reported Outcomes Measurement Information System. The endpoints will be collected at each post-operative day using a journal. Moreover, endpoints will be collected at the patient's first post-operative appointment. These appointments are scheduled within one-week of the index procedure.\n\nStatistical Analysis: All continuous data will be analyzed using independent 2-group t tests and reported as means ± standard deviations. Categorical data will be compared between the 2 groups using chi-square tests and reported as counts and percentages. A preliminary test to confirm the quality of variances will be conducted prior to utilizing the t test to confirm the appropriate statistical analysis. Nonparametric equivalents Wilcoxon rank-sum and Fisher exact tests will be used as needed for nonnormal distributions and low variable numbers, respectively. A multivariable regression analysis was performed to assess for potential confounding demographic variables."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Eligibility Criteria:\n\nInclusion Criteria:\n\n* All adult patients over age 18 and scheduled for a primary or revision anterior cruciate ligament reconstruction\n\nExclusion Criteria:\n\n* Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact anterior cruciate ligament reconstruction'}, 'identificationModule': {'nctId': 'NCT03818932', 'briefTitle': 'Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Henry Ford Health System'}, 'officialTitle': 'Traditional vs. Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '123192'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-Operative Non Opioid Pain Protocol', 'description': 'Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam', 'interventionNames': ['Drug: Celecoxib', 'Drug: Ketorolac', 'Drug: Gabapentin', 'Drug: Acetaminophen', 'Drug: Diazepam']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Post-Operative Traditional Pain Protocol', 'description': 'Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-acetaminophen', 'interventionNames': ['Drug: Hydrocodone-Acetaminophen']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'description': 'Post-Operative Non Opioid Pain Protocol', 'armGroupLabels': ['Post-Operative Non Opioid Pain Protocol']}, {'name': 'Hydrocodone-Acetaminophen', 'type': 'DRUG', 'otherNames': ['Norco'], 'description': 'Traditionally used narcotic pain protocol', 'armGroupLabels': ['Post-Operative Traditional Pain Protocol']}, {'name': 'Ketorolac', 'type': 'DRUG', 'otherNames': ['Toradol'], 'description': 'Post-Operative Non Opioid Pain Protocol', 'armGroupLabels': ['Post-Operative Non Opioid Pain Protocol']}, {'name': 'Gabapentin', 'type': 'DRUG', 'otherNames': ['Neurotin'], 'description': 'Post-Operative Non Opioid Pain Protocol', 'armGroupLabels': ['Post-Operative Non Opioid Pain Protocol']}, {'name': 'Acetaminophen', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Post-Operative Non Opioid Pain Protocol', 'armGroupLabels': ['Post-Operative Non Opioid Pain Protocol']}, {'name': 'Diazepam', 'type': 'DRUG', 'otherNames': ['Valium'], 'description': 'Post-Operative Non Opioid Pain Protocol', 'armGroupLabels': ['Post-Operative Non Opioid Pain Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}], 'overallOfficials': [{'name': 'Toufic R Jildeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Resident'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Per Request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henry Ford Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Toufic R. Jildeh', 'investigatorAffiliation': 'Henry Ford Health System'}}}}