{"protocolSection":{"identificationModule":{"nctId":"NCT02005601","orgStudyIdInfo":{"id":"2012-016"},"organization":{"fullName":"Hospital for Special Surgery, New York","class":"OTHER"},"briefTitle":"Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?","officialTitle":"Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?"},"statusModule":{"statusVerifiedDate":"2017-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-11"},"primaryCompletionDateStruct":{"date":"2015-05","type":"ACTUAL"},"completionDateStruct":{"date":"2015-08","type":"ACTUAL"},"studyFirstSubmitDate":"2013-12-04","studyFirstSubmitQcDate":"2013-12-06","studyFirstPostDateStruct":{"date":"2013-12-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-03-15","resultsFirstSubmitQcDate":"2017-07-27","resultsFirstPostDateStruct":{"date":"2017-08-29","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-07-27","lastUpdatePostDateStruct":{"date":"2017-08-29","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Hospital for Special Surgery, New York","class":"OTHER"}},"descriptionModule":{"briefSummary":"We are investigating the impact of duloxetine (\"Cymbalta\"), a serotonin and norepinephrine reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores 2 weeks after TKA."},"conditionsModule":{"conditions":["Total Knee Arthroplasty"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":106,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.","interventionNames":["Drug: Duloxetine 60mg"]},{"label":"Control","type":"PLACEBO_COMPARATOR","description":"Patients will receive 0mg of duloxetine","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.","armGroupLabels":["Control"]},{"type":"DRUG","name":"Duloxetine 60mg","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.","armGroupLabels":["Duloxetine"],"otherNames":["Cymbalta"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"NRS Pain With Ambulation at 2 Weeks","description":"When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?","timeFrame":"2 weeks after surgery"}],"secondaryOutcomes":[{"measure":"Total Daily Opioid Use (mg Oral Morphine Equivalents)","description":"Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.","timeFrame":"POD 1"},{"measure":"Nausea Severity","description":"Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).","timeFrame":"POD 1"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon\n* Age 25 to 75 years\n* Planned use of regional anesthesia\n* Ability to follow study protocol\n* English speaking (primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)\n* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate\n\nExclusion Criteria:\n\n* Concurrent use of duloxetine or other SNRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, zolmitriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort\n* Hepatic insufficiency\n* Renal insufficiency\n* Patients younger than 25 years old and older than 75\n* Patients intending to receive general anesthesia\n* Allergy or intolerance to one of the study medications\n* Patients with an ASA of IV\n* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)\n* Chronic opioid use (taking opioids for longer than 3 months)\n* Patients with major prior ipsilateral open knee surgery","healthyVolunteers":false,"sex":"ALL","minimumAge":"25 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jacques T YaDeau, MD, PhD","affiliation":"Hospital for Special Surgery, New York","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Hospital for Special Surgery","city":"New York","state":"New York","zip":"10021","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Duloxetine","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.\n\nDuloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"id":"FG001","title":"Control","description":"Patients will receive 0mg of duloxetine\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"53"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"53"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Duloxetine","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.\n\nDuloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"id":"BG001","title":"Control","description":"Patients will receive 0mg of duloxetine\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"106"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"67","lowerLimit":"61","upperLimit":"71"},{"groupId":"BG001","value":"63","lowerLimit":"57","upperLimit":"67"},{"groupId":"BG002","value":"64","lowerLimit":"59","upperLimit":"70"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"26"},{"groupId":"BG002","value":"54"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"52"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"3"},{"groupId":"BG002","value":"6"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"50"},{"groupId":"BG001","value":"46"},{"groupId":"BG002","value":"96"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"48"},{"groupId":"BG001","value":"48"},{"groupId":"BG002","value":"96"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"53"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"106"}]}]}]},{"title":"Body Mass Index","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"kg/m^2","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"31","lowerLimit":"27","upperLimit":"36"},{"groupId":"BG001","value":"31","lowerLimit":"27","upperLimit":"35"},{"groupId":"BG002","value":"31","lowerLimit":"27","upperLimit":"35"}]}]}]},{"title":"Knee pain severity with ambulation","description":"Knee pain severity assessed on Numeric Pain Rating scale, which range from 0 (no pain) to 10 (worst pain)","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Units on a scale","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5.8","spread":"2.5"},{"groupId":"BG001","value":"5.2","spread":"2.6"},{"groupId":"BG002","value":"5.5","spread":"2.6"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"NRS Pain With Ambulation at 2 Weeks","description":"When considering the pain in the knee in which you are having/had surgery, on a scale of 0-10, with 0 being no pain and 10 being pain as bad as you can imagine, how would you describe your level of pain in the last 24 hours during ambulation?","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"NRS pain score","timeFrame":"2 weeks after surgery","groups":[{"id":"OG000","title":"Duloxetine","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.\n\nDuloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"id":"OG001","title":"Control","description":"Patients will receive 0mg of duloxetine\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3.5","spread":"2.1"},{"groupId":"OG001","value":"3.8","spread":"2.3"}]}]}]},{"type":"SECONDARY","title":"Total Daily Opioid Use (mg Oral Morphine Equivalents)","description":"Total daily opioid use (including PO, PCEA, IV, subcutaneous, IV push) in mg oral morphine equivalents on POD 1.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg oral morphine equivalents","timeFrame":"POD 1","groups":[{"id":"OG000","title":"Duloxetine","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.\n\nDuloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"id":"OG001","title":"Control","description":"Patients will receive 0mg of duloxetine\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"57.8","spread":"28.4"},{"groupId":"OG001","value":"72.7","spread":"34.9"}]}]}]},{"type":"SECONDARY","title":"Nausea Severity","description":"Nausea severity measured using Likert scale ranging from 0 (none) to 10 (severe).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"POD 1","groups":[{"id":"OG000","title":"Duloxetine","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.\n\nDuloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."},{"id":"OG001","title":"Control","description":"Patients will receive 0mg of duloxetine\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"53"},{"groupId":"OG001","value":"53"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"2.2"},{"groupId":"OG001","value":"2.3","spread":"3.4"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"3 months","eventGroups":[{"id":"EG000","title":"Duloxetine","description":"Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken preoperatively. Starting on postoperative day (POD) 1, patients will take one capsule once a day until end of POD14.\n\nDuloxetine 60mg: Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.","deathsNumAffected":0,"deathsNumAtRisk":53,"seriousNumAffected":0,"seriousNumAtRisk":53,"otherNumAffected":4,"otherNumAtRisk":53},{"id":"EG001","title":"Control","description":"Patients will receive 0mg of duloxetine\n\nPlacebo: Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.","deathsNumAffected":0,"deathsNumAtRisk":53,"seriousNumAffected":0,"seriousNumAtRisk":53,"otherNumAffected":3,"otherNumAtRisk":53}],"otherEvents":[{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":53},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":53}]},{"term":"Nausea","organSystem":"General disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":53},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":53}]},{"term":"Headache","organSystem":"General disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":53},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":53}]},{"term":"Somnolence","organSystem":"General disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":53},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":53}]},{"term":"SIADH","organSystem":"Endocrine disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":53},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":53}]},{"term":"Insomnia","organSystem":"Psychiatric disorders","sourceVocabulary":"Other","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":53},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":53}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Dr. Jacques Yadeau","organization":"Hospital for Special Surgery","email":"yadeauj@hss.edu","phone":"212-606-1206"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D000068736","term":"Duloxetine Hydrochloride"}],"ancestors":[{"id":"D013876","term":"Thiophenes"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D006573","term":"Heterocyclic Compounds, 1-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"}]}},"hasResults":true}