Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:28 AM
Study NCT ID:
NCT07485803
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A RCT Using Methadone in the Management of Post-Operative Pain in Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid use for 48 hours post-operatively', 'timeFrame': '48 hours after TKA procedure', 'description': 'Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.'}], 'secondaryOutcomes': [{'measure': 'Defense and Veterans Pain Scale', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Patients will keep a log to track their pain after surgery on a scale of 0-10.'}, {'measure': 'Opioid-Related Symptom Distress Scale (ORSDS)', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Patients will complete the survey to track opioid-related side effects'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Patients will complete survey to monitor sleeping habits'}, {'measure': 'Total opioid usage over 2 weeks post-operatively', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption.'}, {'measure': 'Knee Society Score', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Patient reported outcome'}, {'measure': 'KOOS-12 Knee Survey', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Patient reported outcome'}, {'measure': 'Veterans Rand 12-Item Health Survey (VR-12)', 'timeFrame': '2 weeks after TKA procedure', 'description': 'Patient reported outcome'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain management', 'TKA', 'methadone'], 'conditions': ['Total Knee Arthroplasty']}, 'referencesModule': {'references': [{'pmid': '21173206', 'type': 'BACKGROUND', 'citation': 'Kharasch ED. Intraoperative methadone: rediscovery, reappraisal, and reinvigoration? Anesth Analg. 2011 Jan;112(1):13-6. doi: 10.1213/ANE.0b013e3181fec9a3. No abstract available.'}, {'pmid': '29847382', 'type': 'BACKGROUND', 'citation': 'Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.'}, {'pmid': '37638083', 'type': 'BACKGROUND', 'citation': 'Friesgaard KD, Brix LD, Kristensen CB, Rian O, Nikolajsen L. Clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy: a randomised, blinded clinical trial. BJA Open. 2023 Aug 5;7:100219. doi: 10.1016/j.bjao.2023.100219. eCollection 2023 Sep.'}, {'pmid': '25911660', 'type': 'BACKGROUND', 'citation': 'Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163.'}, {'pmid': '25694266', 'type': 'BACKGROUND', 'citation': 'Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19.'}, {'pmid': '28887020', 'type': 'BACKGROUND', 'citation': 'Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17.'}, {'pmid': '33036845', 'type': 'BACKGROUND', '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': "The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Provision of signed and dated informed consent from\n2. Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.\n3. Age 21- 75\n4. Unilateral total knee arthroplasty at Colorado Joint Replacement\n5. All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment\n6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.\n\nExclusion Criteria:\n\n1. Narcotic use in the past 6 weeks\n2. Current or previous history of drug and alcohol abuse\n3. Tobacco use in the previous 90 days\n4. Treatment with another investigational drug\n5. Patients that cannot receive spinal anesthesia\n6. Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'\n7. Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility\n8. Obstructive sleep apnea\n9. Morbid obesity (BMI \\>40)\n10. Patients with liver disease.\n11. Significant kidney disease - stage 3 CKD or greater\n12. Pregnant or nursing females\n13. Baseline QTc \\>480\n14. severe COPD (GOLD 3 or 4)\n15. home oxygen requirement"}, 'identificationModule': {'nctId': 'NCT07485803', 'briefTitle': 'A RCT Using Methadone in the Management of Post-Operative Pain in Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'A Prospective, Randomized Trial Utilizing Methadone in the Management of Post-Operative Pain in Total Knee Replacement', 'orgStudyIdInfo': {'id': '2387801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methadone', 'description': 'Patient will receive one perioperative dose of IV methadone prior to their surgical procedure in addition to standard of care medications.', 'interventionNames': ['Drug: Methadone']}, {'type': 'NO_INTERVENTION', 'label': 'No medication', 'description': 'Patient will not receive only the standard of care medications for their procedure.'}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'description': 'Subjects randomized to receive methadone will be given one dose of methadone 0.15mg/kg intravenously dosed based on ideal body weight administered by the anesthesia team prior to surgical incision', 'armGroupLabels': ['Methadone']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Makenna Hemmerle', 'role': 'CONTACT', 'email': 'makenna.hemmerle@adventhealth.com', 'phone': '303-260-2951'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Joseph Assini', 'investigatorAffiliation': 'AdventHealth'}}}}