Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
Study NCT ID:
NCT04003350
Status:
COMPLETED
Last Update Posted:
2019-07-01
First Post:
2019-06-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D014147', 'term': 'Tramadol'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D000077239', 'term': 'Meloxicam'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'C011301', 'term': 'metaxalone'}, {'id': 'D064098', 'term': 'Esomeprazole'}], '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'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-27', 'studyFirstSubmitDate': '2019-06-21', 'studyFirstSubmitQcDate': '2019-06-27', 'lastUpdatePostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative pain', 'timeFrame': 'Postsurgery days 1-30', 'description': 'Measured via Visual Analog scale (0-100mm)'}, {'measure': 'Opioid related side effects', 'timeFrame': 'post-surgery days 1-30', 'description': 'Severity measured via Visual Analog scale (0-100mm)'}], 'secondaryOutcomes': [{'measure': 'opioid consumption', 'timeFrame': 'post-surgery weeks 1-4', 'description': 'morphine milligram equivalent'}, {'measure': 'opioid consumption', 'timeFrame': 'post-surgery weeks 1-4', 'description': 'number of pills consumed'}, {'measure': 'number of opioid refills', 'timeFrame': 'post-surgery weeks 1-4', 'description': 'number of times subjects asked to have an opioid prescription refilled during post-operative period'}, {'measure': '90 day complications', 'timeFrame': 'post-surgery 90 days', 'description': 'collection of all post-operative medical complications within the first 90 days after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis Knee']}, 'referencesModule': {'references': [{'pmid': '33036845', 'type': 'DERIVED', 'citation': 'Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.\n\nPURPOSE:\n\n1. To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.\n2. To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.\n* ASA I - III\n* Spinal anesthesia\n* All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases\n* Male and Female over 18 who are willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Opioid use within 3 months preoperatively\n* Inability to take the protocol medications\n* Anticoagulant other than aspirin\n* Contraindication to regional anesthesia\n* Non-english speaking\n* ASA IV or greater\n* Psychiatric or cognitive disorders\n* Allergy/contraindications to protocol medications.\n* Renal insufficiency with Cr \\> 2.0 or hepatic failure\n* General anesthesia\n* Sensory/motor disorder involving the operative limb'}, 'identificationModule': {'nctId': 'NCT04003350', 'briefTitle': 'The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rothman Institute Orthopaedics'}, 'officialTitle': 'The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2019MAUSTKA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid Regimen', 'description': 'Weeks 1-4\n\n* Oxycodone 5 mg PRN q4h (30 tablets)\n* Tramadol 50 mg PRN q6h (30 tablets)', 'interventionNames': ['Drug: Oxycodone', 'Drug: Tramadol']}, {'type': 'EXPERIMENTAL', 'label': 'Multimodal pain regimen with PRN opioids', 'description': 'Weeks 1-4\n\n* Tylenol 1000 mg q8h (standing)\n* Meloxicam 15 mg qD (standing).\n* Gabapentin 200 mg BID (with morning and evening Tylenol dose)\n* Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)\n* Esomeprazole 20mg daily if not already on another H2 blocker or PPI\n* Oxycodone 5 mg PRN q4h (30 tablets)\n* Tramadol 50 mg PRN q6h (30 tablets)', 'interventionNames': ['Drug: Oxycodone', 'Drug: Tramadol', 'Drug: Tylenol', 'Drug: Meloxicam', 'Drug: Gabapentin', 'Drug: Metaxalone', 'Drug: Esomeprazole 20mg']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'description': 'Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids', 'Opioid Regimen']}, {'name': 'Tramadol', 'type': 'DRUG', 'description': 'Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids', 'Opioid Regimen']}, {'name': 'Tylenol', 'type': 'DRUG', 'description': 'Tylenol 1000 mg: take as needed every 8 hours', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids']}, {'name': 'Meloxicam', 'type': 'DRUG', 'description': 'Meloxicam 15 mg as need once per day', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids']}, {'name': 'Gabapentin', 'type': 'DRUG', 'description': '•Gabapentin 200 mg with morning and evening Tylenol dose', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids']}, {'name': 'Metaxalone', 'type': 'DRUG', 'description': 'Metaxalone 800mg TID', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids']}, {'name': 'Esomeprazole 20mg', 'type': 'DRUG', 'description': 'Esomeprazole 20mg daily', 'armGroupLabels': ['Multimodal pain regimen with PRN opioids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19148', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Rothman Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rothman Institute Orthopaedics', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}