Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 5:28 AM
Study NCT ID:
NCT04471233
Status:
COMPLETED
Last Update Posted:
2024-10-01
First Post:
2020-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Care providers, and investigators will all be blinded to patient group identity.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Intervention is preoperative and 14 days postoperatively. Patients will be assigned to either multimodal analgesia regimen. No crossing over of patients will occur.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-27', 'studyFirstSubmitDate': '2020-05-21', 'studyFirstSubmitQcDate': '2020-07-09', 'lastUpdatePostDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess influence of sex and multimodal analgesia regimens on acute postoperative pain scores at 48 hours postoperatively, in patients undergoing TKA.', 'timeFrame': '48 hours', 'description': 'Pain control measured by 100mm visual analogue scale (VAS) while at rest 48 hours after the procedure.'}], 'secondaryOutcomes': [{'measure': 'Assess how sex differences and multimodal analgesia regimens influence physical function', 'timeFrame': '26 weeks', 'description': '-Pain measured by Knee Injury and Osteoarthritis Outcome Score (KOOS) of week 4, week 12, week 26 postoperatively, compared to baseline.'}, {'measure': 'Assess how sex differences and multimodal analgesia regimens influence postoperative narcotic medication use', 'timeFrame': '72 hours', 'description': 'Pain control additionally measured by morphine equivalent units (MEq) for 24, 48, and 72 hours after the end of the procedure.'}, {'measure': 'Assess how sex differences and multimodal analgesia regimens influence postoperative narcotic medication cessation', 'timeFrame': '2 weeks', 'description': '-Number of postoperative days to opioid cessation.'}, {'measure': 'Assess how sex differences and multimodal analgesia regimens influence chronic postoperative pain', 'timeFrame': '26 weeks', 'description': '-Chronic: Pain control measured by 100mm visual analogue scale (VAS) (0 corresponding to no pain and 100 corresponding to worst possible pain) while at rest and mobilization at week 1, week 2, week 4-6, week 12, week 26 postoperatively.'}, {'measure': 'Assess how sex differences and multimodal analgesia regimens influence mental health', 'timeFrame': 'week 26', 'description': '-Mental health measured by mental component summary (MCS-12) of VR-12 of week 2, week 4, week 12, week 26 postoperatively, compared to baseline.'}, {'measure': 'Assess how sex differences and multimodal analgesia regimens influence physical function', 'timeFrame': '26 weeks', 'description': '-Physical function measured physical component summary (PCS-12) of Veterans Rand-12 (VR-12) at week 2, week 4, week 12, week 26 postoperatively, compared to baseline.'}, {'measure': 'Assess how sex differences and multimodal analgesia regimens influence range of motion (ROM)', 'timeFrame': '26 weeks', 'description': 'Range of Motion (ROM) of week 2, week 4, week 12, week 26 postoperatively, compared to baseline.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis', 'Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '23794645', 'type': 'BACKGROUND', 'citation': 'Bartley EJ, Fillingim RB. Sex differences in pain: a brief review of clinical and experimental findings. Br J Anaesth. 2013 Jul;111(1):52-8. doi: 10.1093/bja/aet127.'}, {'pmid': '10097000', 'type': 'BACKGROUND', 'citation': 'Berkley KJ. Sex differences in pain. Behav Brain Sci. 1997 Sep;20(3):371-80; discussion 435-513. doi: 10.1017/s0140525x97221485.'}, {'pmid': '18929073', 'type': 'RESULT', 'citation': 'Anderson GD. Gender differences in pharmacological response. Int Rev Neurobiol. 2008;83:1-10. doi: 10.1016/S0074-7742(08)00001-9.'}, {'pmid': '39307204', 'type': 'DERIVED', 'citation': 'Sodhi N, Qilleri A, Aprigliano C, Danoff JR. One Size Does Not Fit All: Women Experience More Pain Than Men After Total Knee Arthroplasty. J Arthroplasty. 2025 Apr;40(4):880-886. doi: 10.1016/j.arth.2024.09.028. Epub 2024 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the influence of sex on postoperative pain, following total knee arthroplasty (TKA). Patients will first be stratified by sex and then be randomized into one of two multimodal analgesic regimen (MAR), which differ in presence of pregabalin. We hypothesize that that acute postoperative pain scores are different over time between males and females and between multimodal analgesic regimens following TKA. Investigators will be blinded to which multimodal group patients are in. Patients will complete surveys in the office, during their hospital stay, and at followup intervals for up to six months.', 'detailedDescription': 'The overall goal of this study is to better understand the influence of patient-sex on postoperative pain perception in men versus women following total knee arthroplasty (TKA) utilizing two different multimodal analgesia regimens.\n\nPregabalin is a neuromuscular antagonist of voltage gated calcium channels at the post-synaptic dorsal horns in the spinal cord and brain. It binds to the alpha-2-delta subunit and interrupts pain signal transmission. The use of pregabalin as part of multimodal pain control has been associated with a decrease in postoperative opioid use.\n\nThis will be a randomized, single-blinded control trial in which patients either will or will not receive pregabalin as part of their multimodal analgesia regimen following TKA. It will be performed at a single institution, with multiple tertiary academic centers.\n\nPatients will first be grouped according to their sex, then randomized into one of two arms:\n\n1. Multimodal analgesia regimen including pregabalin;\n2. Multimodal analgesia regimen not including pregabalin.\n\nFor the intervention group, patient will be provided with an oral preoperative pregabalin dose of 150mg on the day of surgery. Patient will continue pregabalin 75mg two times a day, for two weeks postoperatively. For both both groups, the operative technique and additional perioperative analgesic modalities will follow a standard protocol.\n\nPrimary Endpoint: Acute postoperative pain difference (up to 72 hours), measured by 100mm visual analogue scale (VAS) while at rest and mobilization, between males and females and between multimodal analgesic regimens in patients undergoing TKA.\n\nSecondary Endpoints:\n\n* Pain control measured by 100mm visual analogue scale (VAS) while at rest and mobilization.\n* Pain control additionally measured by morphine equivalent units (MEq).\n* Number of postoperative days to opioid cessation.\n* Pain measured by Knee Injury and Osteoarthritis Outcome Score (KOOS).\n* Physical function measured by KOOS, physical component summary (PCS-12) of VR-12.\n* Mental health measured by mental component summary (MCS-12) of VR-12.\n* Safety will be tracked by adverse reactions reported or observed by investigators. These will be collected via patient communication and review of the medical record.\n* Additionally, severity of common short-term postoperative complications like nausea, vomiting, dizziness, and sedation will be assessed by 100mm VAS.\n\nThe study recruitment phase is estimated to last for 6 months. Subject followup is 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Eligibility will be based on biological sex', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, age 18-80\n4. Undergoing primary unilateral TKA for primary osteoarthritis\n5. English speaking\n6. Patients whose primary residence is in a home and not a facility or rehabilitation center.\n\nExclusion Criteria:\n\n1. Chronic (\\>6 months) use of neuromodulators pregabalin or gabapentin.\n2. Pregnancy or lactation\n3. Prior history of adverse reactions to pregabalin\n4. Coexisting chronic pain condition rated ≥50mm on 100-mm VAS requiring narcotics.\n5. Coexisting condition leading to sedation or dizziness\n6. Kidney disease\n7. History of angioedema\n8. History of depression with suicidal ideation.\n9. Extensive history of opioid/ substance use and/or abuse.\n10. Receiving active or maintenance treatment for cancer or solid organ and/or marrow transplant.\n11. Patient staying less than one night in the hospital.\n12. Patients with a history of chronic obstructive pulmonary disease (COPD) with supplementary oxygen requirements.'}, 'identificationModule': {'nctId': 'NCT04471233', 'briefTitle': 'Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Influence of Patient Sex on Pain Control and Multimodal Analgesia in Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '20-0139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal analgesia regimen including pregabalin', 'description': 'For the pregabalin group, patient will be provided with an oral preoperative pregabalin dose of 150mg on the day of surgery. Patient will continue pregabalin 75mg two times a day, for two weeks postoperatively. For both the intervention and control groups, the operative technique and additional perioperative analgesic modalities will follow a standard protocol', 'interventionNames': ['Other: Multimodal analgesia including pregabalin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multimodal analgesia regimen not including pregabalin', 'description': 'For the non-pregabalin group, patient will be undergo total knee arthroplasty with the same operative technique and additional perioperative analgesic modalities will follow a standard protocol', 'interventionNames': ['Other: Multimodal analgesia not including pregabalin']}], 'interventions': [{'name': 'Multimodal analgesia including pregabalin', 'type': 'OTHER', 'description': 'Standardized protocol for our institution with multiple medications used for pain (NSAIDs, opioids, dexamethasone) and non-narcotic spinal. Patient will be provided with an preoperative pregabalin dose and will continue medication two weeks postoperatively.', 'armGroupLabels': ['Multimodal analgesia regimen including pregabalin']}, {'name': 'Multimodal analgesia not including pregabalin', 'type': 'OTHER', 'description': 'Standardized protocol for our institution with multiple medications used for pain (NSAIDs, opioids, dexamethasone) and non-narcotic spinal.', 'armGroupLabels': ['Multimodal analgesia regimen not including pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health Orthopedic Institute at Great Neck', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}], 'overallOfficials': [{'name': 'Jonathan Danoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}