[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603745":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":83,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Thammasat University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dinalbuphine Sebacate","EXPERIMENTAL","Naldebain 150mg\u002F2mL IM",[13],"Drug: Dinalbuphine Sebacate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Normal saline 2 mL IM",[19],"Drug: Normal Saline",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dinalbuphine Sebacate 150 mg intramuscular injection after spinal anesthesia and adductor canal block in the same side of TKA",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Normal Saline","Normal saline 2 mL intramuscular injection after spinal anesthesia and adddutor canal block",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Supakit Kanitnate, M.D.","CONTACT","+66 899853635","naypeng@hotmail.com",[37],{"facility":5,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Khlong Luang","Changwat Pathum Thani","12120","Thailand","TH",{"type":44,"coordinates":45},"Point",[46,47],100.64578,14.06467,{"lat":47,"lon":46},[50,52],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":51},"naypenf@hotmail.com",{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Nattapol Tammachote, M.D.","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Supakit Kanitnate","Principal investigator","100603745","phase-4-dinalbuphine-sebacate-in-postoperative-pain-control-after-tka-100603745",false,"NCT07140510","Dinalbuphine Sebacate in Postoperative Pain Control After TKA","Effectiveness of Dinalbuphine Sebacate in Postoperative Pain Control Following Total Knee Arthroplasty: A Randomized Double Blinded Placebo-controlled Trial","Naldebain","Inclusion Criteria:\n\n* Osteoarthritic knee patients underwent unilateral primary TKA\n* Age 50-90 years\n* ASA class I-III\n* Participants understand and consent to the protocol of the trial\n\nExclusion Criteria:\n\n* Morbid obesity (BMI\\>40)\n* Knee osteoarthritis from inflammatory knee arthritis, trauma, infection\n* Previous knee surgery\n* Cognitive disorder\n* Liver disease\n* Allergy to NSAIDs, opioids, sesame oil, and benzyl benzoate\n* CYP3A4 inhibitor and inducer drugs used","ALL","50 Years","90 Years",{"count":70,"type":71},100,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty",[77,78],"Osteo Arthritis of the Knee","Total Knee Anthroplasty",[9,64,80,81,82],"Subacute pain","postoperative pain","total knee arthroplasty","NOT_YET_RECRUITING","2025-08-18",{"date":86,"type":87},"2025-08-24","ACTUAL",{"date":89,"type":71},"2025-10",{"date":91,"type":71},"2026-09",{"name":5,"class":6},1]