[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07227064":3,"trial-entities:NCT07227064":94,"trial-summary:NCT07227064":99},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":86,"overall_officials":88,"references":92,"see_also_links":93},"NCT07227064","Pro00147100","Methadone in THA for Post-op Pain and Opioid Reduction","Reduction of Post-op Pain and Opioid Consumption With the Addition of Methadone in Total Hip Arthroplasty: a Double-blind Randomized Control Trial","RECRUITING","2027-01-31","2026-02","2026-02-05","2026-01-12","Medical University of South Carolina","OTHER",true,"This randomized, double-blind controlled trial investigates whether intraoperative intravenous methadone (0.15 mg\u002Fkg based on ideal body weight) reduces acute postoperative pain and opioid consumption in patients undergoing elective total hip arthroplasty under spinal anesthesia with mepivacaine. The primary outcome is patient-reported pain on a visual analog scale (VAS) 30-60 minutes after arrival in the post-anesthesia care unit (PACU). Secondary outcomes include opioid use, pain scores over time, incidence of nausea\u002Fvomiting, and quality of recovery. A total of 162 subjects will be enrolled at MUSC surgical sites.",null,[19,20],"Post Operative Pain","Total Hip Arthroplasty",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE3",{"count":27,"type":28},162,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Methadone","Patients will intraoperatively receive methadone 0.15mg\u002Fkg IV, based on ideal body weight.",[32],[36],{"measure":37,"description":38,"timeFrame":39},"Patient reported pain in the recovery unit after surgery","Patient reported hip pain on a Visual Analog Scale (VAS) from 0-100mm at approximately 30-60 minutes after arriving to the recovery unit after surgery. A lower pain score means a better outcome.","up to 24 hours after surgery ends",[41,45,48,52,56],{"measure":42,"description":43,"timeFrame":44},"Opioid Consumption in the recovery unit","Opioid consumption measured in oral morphine milligram equivalents (MMEs) while the patient is in the PACU (Post-Anesthesia Recovery Unit).","PACU Arrival until PACU Discharge up to 30 days",{"measure":46,"description":47,"timeFrame":39},"Time to first opioid rescue dose","Measured from the PACU arrival time, to the time the first opioid rescue dose is given while in the PACU.",{"measure":49,"description":50,"timeFrame":51},"Pain scores","Visual Analog Score (VAS) 0-100mm reporting hip pain at rest, and with movement. A lower pain score means a better outcome.","PACU, 24 hours, 48 hours, and 72 hours post-operatively.",{"measure":53,"description":54,"timeFrame":55},"Postoperative nausea and\u002For vomiting","Incidence of postoperative nausea and\u002For vomiting after surgery as reported by the patient in a yes\u002Fno questionnaire format.","PACU through 72 hours post-operatively",{"measure":57,"description":58,"timeFrame":59},"Quality of Recovery","Change in quality of recovery score from baseline to 24-hours post-operatively measured using the Quality of Recovery 15 Assessment (QoR-15). This assessment is scored 0-150, with a higher score indicating a better quality of recovery. Each of the 15 questions is on an 11-point numerical rating scale from 0-10, and the selections are added together to result in the total score.","up to 24-hours post-operatively","ALL","18 Years","75 Years",false,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"Inclusion\n\n* Ages 18-75 years of age\n* Undergoing elective primary total hip arthroplasty with mepivacaine in the spinal anesthesia\n\nExclusion\n\n* Allergy to methadone or mepivacaine\n* Severe liver disease defined as Child's Pugh Class C\n* End stage renal disease requiring dialysis\n* Known diagnosis of prolonged QT syndrome\n* Currently pregnant\n* Unable to provide written, informed consent\n* Non-English speaking",[69,70],"ADULT","OLDER_ADULT",[72],{"facility":13,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Charleston","South Carolina","29425","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Haley Nitchie, MHA","CONTACT","843-792-1869","nitchie@musc.edu",{"lat":84,"lon":85},32.77632,-79.93275,[87],{"name":79,"role":80,"phone":81,"email":82},[89],{"name":90,"affiliation":13,"role":91},"Christopher Fatora, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":95,"biomarkers":98},[96,97],"Post-Operative Pain","Total replacement of hip",[],{"nct_id":4,"found":15,"summary":100,"prompt_version":110},{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is a randomized, double-blind controlled trial, meaning participants are randomly assigned to groups and neither you nor your doctors will know which treatment you receive. It plans to enroll 162 participants.","completed","Methadone for Post-Surgery Pain After Hip Replacement","This study is looking at whether giving methadone (a pain medication) during total hip replacement surgery can reduce pain and the need for other opioid pain medicines afterward. You might be able to join if you are between 18 and 75 years old and are having an elective total hip replacement with a specific type of spinal anesthesia. The researchers want to see if methadone helps with your pain levels in the recovery room within 24 hours after surgery. This study plans to enroll 162 people, but its current status is unclear.","Your pain will be measured for up to 24 hours after surgery ends.",92,"Patients will receive an intravenous (IV) dose of methadone during their total hip replacement surgery. Your pain will be measured in the recovery unit after surgery.","Not stated in the trial record.",[32],"v2"]