[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100503137":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":26,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":26,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":26,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":26,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Brugmann University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"S Group","ACTIVE_COMPARATOR","Patients receiving sufentanil during induction of general anesthesia",[13],"Drug: Sufentanil Citrate",{"label":15,"type":16,"description":17,"interventionNames":18},"M Group","EXPERIMENTAL","Patients receiving methadone during induction of general anesthesia",[19],"Drug: Methadone Hydrochloride",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methadone Hydrochloride","Classic induction of anesthesia (opioid, hypnotic and curare) but the team is blinded to the opioid used (sufentanil or methadone), which is prepared in identical syringes by the pharmacy",[15],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Sufentanil Citrate",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Riccardo Mora, MD","CONTACT","00393292199132","riccardo.mora@chu-brugmann.be",[37],{"facility":38,"status":39,"city":40,"state":26,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHU Brugmann","RECRUITING","Brussels","1020","Belgium","BE",{"type":45,"coordinates":46},"Point",[47,48],4.34878,50.85045,{"lat":48,"lon":47},[51],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Tatiana Besse-Hammer","Head Physician of the Clinical Research Unit","100503137","phase-3-intraoperative-methadone-for-the-prevention-of-postoperative-pain-100503137",false,"NCT05831345","Intraoperative Methadone for the Prevention of Postoperative Pain","Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery","Inclusion Criteria:\n\n* Age between 18 and 80 years old\n* ASA 1-3 status\n* Elective partial or total hip and knee arthroplasty\n\nExclusion Criteria:\n\n* Patient refusal\n* Preoperative renal failure (serum creatinine \\> 2 mg\u002FdL or 1.5-fold\n* Increase in basal plasma creatinine or GFR \\\u003C 90 ml\u002Fmin\u002F1.73m2)\n* Significant hepatic dysfunction (PT \\\u003C50% or increase in 3 times basal transaminases)\n* Known heart failure\n* Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)\n* Known methadone or sufentanil allergy\n* Preoperative opioid use or history of opioid abuse\n* Pregnancy and breastfeeding.","ALL","18 Years","80 Years",{"count":67,"type":68},80,"ESTIMATED","INTERVENTIONAL",[71],"PHASE3","The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively.\n\nMethadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed.\n\nIt may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient.\n\nIntraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.",[74],"Orthopedic Surgery","2025-02-05",{"date":77,"type":78},"2025-02-07","ACTUAL",{"date":80,"type":78},"2023-02-28",{"date":82,"type":68},"2025-12",{"name":5,"class":6},1]