Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-03-03 @ 4:15 AM
Study NCT ID:
NCT06691633
Status:
COMPLETED
Last Update Posted:
2024-11-15
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Clinical staff other than the anesthesia providers'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized cohort analysis study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-13', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Opioid Use', 'timeFrame': '2 weeks', 'description': 'Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA'}, {'measure': 'Total opioid usage over two weeks', 'timeFrame': '2 weeks', 'description': 'total daily opioid usage (as measured in MME) during the first 14 days following TKA'}, {'measure': 'Visual Analogue Scale pain score', 'timeFrame': '2 weeks', 'description': 'Visual Analogue Scale knee pain score (minimum value: 0, maximum value: 10). Higher scores equate to a worse outcome (a score of zero = pain free).'}], 'secondaryOutcomes': [{'measure': 'Hospital Length of Stay', 'timeFrame': 'Up to 2 weeks', 'description': 'Number of days patient was an inpatient in the hospital prior to discharge date'}, {'measure': 'Discharge location', 'timeFrame': '2 weeks', 'description': 'Whether patient was discharged to home or to a rehab facility'}, {'measure': 'Two and six-week narcotic refill', 'timeFrame': '6 weeks', 'description': 'Whether patient was prescribed a two week and/or six-week postoperative narcotic refill'}, {'measure': 'Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score', 'timeFrame': 'preoperatively and 6 weeks (± 2 weeks) postoperatively', 'description': 'The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR.) is a survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. The minimum value is 0, the maximum value is 100. A higher score means a better outcome.'}, {'measure': 'ROM', 'timeFrame': 'preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively', 'description': 'active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'knee', 'total knee arthroplasty', 'prospective RCT', 'preoperative analgesia', 'Methadone'], 'conditions': ['Osteoarthritis (OA) of the Knee']}, 'referencesModule': {'references': [{'pmid': '15501692', 'type': 'BACKGROUND', 'citation': 'Ferrari A, Coccia CP, Bertolini A, Sternieri E. Methadone--metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004 Dec;50(6):551-9. doi: 10.1016/j.phrs.2004.05.002.'}, {'pmid': '9783723', 'type': 'BACKGROUND', 'citation': 'Ebert B, Thorkildsen C, Andersen S, Christrup LL, Hjeds H. Opioid analgesics as noncompetitive N-methyl-D-aspartate (NMDA) antagonists. Biochem Pharmacol. 1998 Sep 1;56(5):553-9. doi: 10.1016/s0006-2952(98)00088-4.'}, {'pmid': '19309064', 'type': 'BACKGROUND', 'citation': 'Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.'}, {'pmid': '10215686', 'type': 'BACKGROUND', 'citation': 'Davis AM, Inturrisi CE. d-Methadone blocks morphine tolerance and N-methyl-D-aspartate-induced hyperalgesia. J Pharmacol Exp Ther. 1999 May;289(2):1048-53.'}, {'pmid': '1609941', 'type': 'BACKGROUND', 'citation': 'Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.'}, {'pmid': '19844772', 'type': 'BACKGROUND', 'citation': 'Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.'}, {'pmid': '25271179', 'type': 'BACKGROUND', 'citation': 'Bahreini M, Jalili M, Moradi-Lakeh M. A comparison of three self-report pain scales in adults with acute pain. J Emerg Med. 2015 Jan;48(1):10-8. doi: 10.1016/j.jemermed.2014.07.039. Epub 2014 Sep 27.'}, {'pmid': '26708043', 'type': 'BACKGROUND', 'citation': 'Aasvang EK, Lunn TH, Hansen TB, Kristensen PW, Solgaard S, Kehlet H. Chronic pre-operative opioid use and acute pain after fast-track total knee arthroplasty. Acta Anaesthesiol Scand. 2016 Apr;60(4):529-36. doi: 10.1111/aas.12667. Epub 2015 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA.\n\nThe main questions it aims to answer are:\n\n* What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty?\n* Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty\n\nParticipants will:\n\n* be randomized into one of two groups\n* undergo a primary TKA\n* complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA\n* return to office at 2 weeks and 6 weeks postop for follow-up\n* complete additional questionnaires at 2 weeks and 6 weeks postop'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patient age is 21-89 at time of surgery\n2. Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis\n3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document\n4. Patient is able to read and speak English.\n\nExclusion Criteria:\n\n1. Patient is under the age of 21\n2. Patient's primary diagnosis is not osteoarthritis\n3. Patient is unable to read and speak English\n4. History of liver or kidney disease,\n5. Known or suspected GI obstruction\n6. Hypersensitivity to methadone\n7. Patients with significant respiratory depression\n8. Pregnant or nursing females"}, 'identificationModule': {'nctId': 'NCT06691633', 'briefTitle': 'Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '23.0752'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methadone Group', 'description': 'Participant receives a one-time preoperative dose of 10 mg of methadone', 'interventionNames': ['Drug: Preoperative Methadone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycodone Group', 'description': 'participant receives a one-time preoperative dose of 10 mg of oral oxycodone', 'interventionNames': ['Drug: Preoperative Oxycodone']}], 'interventions': [{'name': 'Preoperative Methadone', 'type': 'DRUG', 'description': 'patient receives a one-time preoperative dose of 10 mg of methadone', 'armGroupLabels': ['Methadone Group']}, {'name': 'Preoperative Oxycodone', 'type': 'DRUG', 'description': 'patient receives a one-time preoperative dose of 10 mg of oral oxycodone', 'armGroupLabels': ['Oxycodone Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'UofL Health', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Rodolfo Zamora, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Louisville'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Will not share IPD if it is not a requirement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic Surgeon', 'investigatorFullName': 'Arthur Malkani', 'investigatorAffiliation': 'University of Louisville'}}}}