[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541300":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":51,"studyPopulation":39,"armGroups":52,"interventions":65,"overallOfficials":39,"centralContacts":71,"locations":77,"responsibleParty":98,"collaborators":39,"id":101,"slug":39,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":39,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":39,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":79,"whyStopped":39,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Thammasat University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Pain score","Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)","Every 6 hours after surgery for 2 days, then twice a day for 2 weeks, then once a week until 12 week after surgery.",[14,18,22,26,28,31,35],{"measure":15,"description":16,"timeFrame":17},"Morphine consumption","Total morphine consumption in hospital (mg)","72 hours after surgery",{"measure":19,"description":20,"timeFrame":21},"Range of motion","Using long arm goniometer (degrees)","24 hour, 48 hour, 2 week, 6 week and 12 week after surgery",{"measure":23,"description":24,"timeFrame":25},"Knee society score","report in point (0-100, 0 mean worst, 100 mean best)","2 week, 6 week and 12 week after surgery",{"measure":27,"description":24,"timeFrame":25},"Knee injury and Osteoarthritis Outcome Score (KOOS)",{"measure":29,"description":30,"timeFrame":21},"Sedation score","report in point (0-100, 0 mean best, 100 mean worst)",{"measure":32,"description":33,"timeFrame":34},"Incidence of Somnolence and dizziness","Using scale \"Mild, moderate and severe\"","everyday until 14 days then once a week until 12 weeks after surgery",{"measure":36,"description":37,"timeFrame":38},"Total hospital stay","Number of days the patient stays for surgery","up to 1 week",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":46},"QUADRUPLE",[47,48,49,50],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","After surgery is complete, you will be randomly assigned to receive painkillers Mirogabalin or Pregabalin along with other standard medications.\n\nSurgery by Mirogabalin group: Participants received 5 mg of mirogabalin, taken as half a tablet, every day.\n\nTwice a day, after breakfast and dinner, for 6 weeks. In the pregabalin group: Participants received 50 mg of pregabalin, one tablet taken daily.\n\nTwice a day, after breakfast and dinner, for 6 weeks",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Mirogabalin","EXPERIMENTAL","Participants will receive 5 mg of mirogabalin, taken as half a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.",[58],"Drug: Mirogabalin",{"label":60,"type":61,"description":62,"interventionNames":63},"Pregabalin","ACTIVE_COMPARATOR","Participants will receive 50 mg of pregabalin, taken as a tablet, every day twice a day, after breakfast and dinner, for 6 weeks.",[64],"Drug: Pregabalin",[66,69],{"type":67,"name":54,"description":56,"armGroupLabels":68,"otherNames":39},"DRUG",[54],{"type":67,"name":60,"description":62,"armGroupLabels":70,"otherNames":39},[60],[72],{"name":73,"role":74,"phone":75,"phoneExt":39,"email":76},"Yot Tanariyakul, M.D.","CONTACT","+66863930257","y.tanariyakul@gmail.com",[78],{"facility":5,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"RECRUITING","Khlong Luang","Changwat Pathum Thani","12120","Thailand","TH",{"type":86,"coordinates":87},"Point",[88,89],100.64578,14.06467,{"lat":89,"lon":88},[92,94,96],{"name":73,"role":74,"phone":93,"phoneExt":39,"email":76},"6683930257",{"name":73,"role":95,"phone":39,"phoneExt":39,"email":39},"PRINCIPAL_INVESTIGATOR",{"name":97,"role":95,"phone":39,"phoneExt":39,"email":39},"Krit Boontanapibul, M.D.",{"type":95,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Yot Tanariyakul","Principle investigator","100541300",false,"NCT06328062","Comparing Efficiency of Mirogabalin and Pregabalin in Primary TKA","Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty. a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age 50-85 years old\n2. Unilateral primary osteoarthritis undergoing primary TKA\n3. ASA I-III\n\nExclusion Criteria:\n\n1. GFR \\<60\n2. Allergy to drug in this study\n3. Cannot underwent spinal anesthesia and adductor canal block\n4. Taking gabapentinoid within 3 months before surgery\n5. History of previous knee surgery\n6. Severe liver disease","ALL","50 Years","85 Years",{"count":111,"type":112},80,"ESTIMATED","INTERVENTIONAL",[115],"NA","The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.\n\nThe main question\\[s\\] it aims to answer are:\n\n• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.\n\nParticipants will randomized to mirogabalin or pregabalin group and will take the drug for 6 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.",[118,119,120],"Pain Postoperative","Osteoarthritis","Total Knee Arthroplasty",[122,123,124,125],"mirogabalin","pregabalin","pain postoperative","TKA","2025-04-05",{"date":128,"type":129},"2025-04-09","ACTUAL",{"date":131,"type":129},"2024-04-01",{"date":133,"type":112},"2025-05-31",{"name":5,"class":6},1]