[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580889":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":69,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":26,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Unity Health Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm with Methadone","EXPERIMENTAL","During the spinal surgery intervention, participants receive a single dose of 0.2mg\u002Fkg of Methadone rectally, after anesthesia induction.",[13],"Drug: Rectal Methadone administer during spinal surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","During the spinal surgery intervention, participants receive a single dose of saline solution rectally after anesthesia induction.",[19],"Other: Placebo: Rectal saline solution",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Rectal Methadone administer during spinal surgery","Rectal Methadone administered during spinal surgery for post-operative pain management",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo: Rectal saline solution","Placebo: Rectal saline solution single dose received during surgery",[15],[32],{"name":33,"affiliation":34,"role":35},"Sergio Pereira, MD PhD","St. Michael's Hospital. Unity Health Toronto","PRINCIPAL_INVESTIGATOR",[37,42],{"name":33,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","416-360-4000","49308","Sergio.Pereira@unityhealth.to",{"name":43,"role":38,"phone":44,"phoneExt":45,"email":46},"Janneth A Pazmino-Canizares, MSc","4168646060","49561","Janneth.Pazmino-Canizares@unityhealth.to",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"St. Michael's Hospital","RECRUITING","Toronto","Ontario","M5B 1W8","Canada","CA",{"type":57,"coordinates":58},"Point",[59,60],-79.39864,43.70643,{"lat":60,"lon":59},[63,67],{"name":64,"role":38,"phone":39,"phoneExt":65,"email":66},"Sergio Pereira, MD. PhD","49803","sergio.pereira@unityhealth.to",{"name":68,"role":38,"phone":44,"phoneExt":45,"email":46},"Janneth Pazmino-Canizares, MSc",{"type":70,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[72],{"name":73,"class":6},"AFP Innovation Fund","100580889","phase-4-perioperative-rectal-methadone-in-spine-surgery-100580889",false,"NCT06843174","Perioperative Rectal Methadone in Spine Surgery","PROMISE","Inclusion Criteria:\n\n1. 18 to 65 years-old.\n2. Elective spinal surgery with fusion of one or more sacral, lumbar, thoracic, and\u002For cervical levels\n3. Capacity to provide informed consent\n4. For participants of childbearing potential, use of contraception.\n\nExclusion Criteria:\n\n1. American Society of Anesthesiologists Physical Status \\> IV\n2. Hypersensitivity to the active substance (methadone hydrochloride) or other opioid analgesics or to any ingredient in the formulation\n3. Pregnant or nursing participants\n4. Known or suspected mechanical gastrointestinal obstruction\n5. Acute respiratory depression, elevated carbon dioxide levels in the blood, cor pulmonale, or pulmonary disease necessitating home oxygen therapy\n6. Acute alcohol intoxication, delirium tremens, and convulsive disorders secondary to alcohol intoxication\n7. Severe central nervous system depression, increased intracranial pressure, or head injury\n8. Use of monoamine oxidase (MAO) inhibitors, such as isocarboxazid, phenelzine, selegiline, and tranylcypromine, within 14 days of enrollment\n9. Diarrhea associated with pseudomembranous colitis caused by cephalosporins, lincomycins, or penicillins\n10. Preoperative renal insufficiency or failure\n11. Significant liver disease (cirrhosis or hepatic failure)\n12. History of opioid use disorder within the last 3 months\n13. Patients taking more than 90 mg of morphine equivalents daily\n14. Poor comprehension of the English language\n15. Patients who are likely to remain intubated postoperatively\n16. QT interval \\> 500ms on preoperative ECG","ALL","18 Years","65 Years",{"count":85,"type":86},40,"ESTIMATED","INTERVENTIONAL",[89],"PHASE4","Patients undergoing spinal surgery require pain control medication after their surgery. Investigators have successfully used intravenous Methadone to manage pain after surgery. However, doctors in Canada do not have the intravenous form of Methadone to prescribe to their patients. The investigators in Canada propose a pilot trial to investigate whether Methadone administered rectally could be used to manage pain after spinal surgery.\n\nThe main questions are:\n\n1. Are investigators able to recruit participants for this trial and learn from this study to plan a larger trial?\n2. Does Methadone administered rectally during surgery, reduce participants' pain intensity, use less pain medication, and have a better recovery after surgery? Investigators will compare Methadone to a placebo (a look-alike substance that contains no drug) to see if Methadone works to manage pain after surgery better than the usual pain management.\n\nParticipants will:\n\n* receive either Methadone or placebo during surgery.\n* be asked some questions about their pain during days 1 to 3 after surgery\n* be contacted by phone to ask about their recovery\n\nAt this time, the study aims to recruit 40 participants from St. Michael's Hospital, to learn whether it will be feasible to plan a larger study.",[92,93,94],"Spinal Surgery","Post-operative Care","Post-operative Pain Management",[96,97,98],"Intraoperative Methadone","Rectal Methadone administration","spinal surgery post-operative pain management","2025-03-25",{"date":101,"type":102},"2025-03-30","ACTUAL",{"date":104,"type":102},"2025-02-19",{"date":106,"type":86},"2026-08",{"name":5,"class":6},1]