[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07517679":3,"trial-entities:NCT07517679":108,"trial-summary:NCT07517679":112},{"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":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":71,"minimum_age":72,"maximum_age":73,"healthy_volunteers":15,"eligibility_criteria":74,"std_ages":85,"locations":88,"central_contacts":104,"overall_officials":105,"references":106,"see_also_links":107},"NCT07517679","111197","Methadone for Post-operative Spine Surgery","Effect of Post-Induction Methadone on Postoperative Pain, Opioid Use, and Recovery in Spine Surgery","RECRUITING","2027-04","2026-06","2026-07-20","2026-06-10","Brandon Knopp","OTHER",false,"The goal of this prospective cohort study is to evaluate the clinical effects of post-induction methadone on perioperative pain control, opioid requirements, and recovery outcomes in adult patients undergoing elective spine surgery, with the goal of improving postoperative analgesia and enhancing recovery efficiency. The main questions it aims to answer are the perioperative pain control and opioid requirements between the two groups.\n\nPost-induction methadone can offer equivalent or improved pain control following major spine procedures and reduce intra- and postoperative opioid requirements, improve perioperative pain control and shorten PACU stay.\n\nResearchers will compare perioperative opioid use (morphine equivalents (ME), during the intraoperative and postoperative periods (PACU and 24-hour totals) between the standard intraoperative opioid regimen group and the methadone group.\n\nPatients will be randomized preoperatively to one of two groups: (both groups will receive additional multimodal pain control including opioids, not including methadone, as needed) Standard intraoperative opioid regimen (control) Methadone 0.2 mg\u002Fkg (max 20 mg)\n\nIf the patient is in the methadone group, the patient will receive a predetermined dose of Methadone (0.2mg\u002Fkg) intravenously after induction (they are given medications to sleep for surgery). They will proceed with surgery, and all patients will receive standard of care management regardless of whether they receive Methadone or not. Following the surgery, all study participants will be asked at set times about their pain level and, 24 hours after the surgery, will be asked if they are satisfied with their pain management for the surgery. Data regarding their clinical progression and pain control\u002Fpain medication requirements will be collected for the duration of the hospitalization.",null,[19],"Pain, Postoperative",[21,22,23],"methadone","opioids","spine surgery","INTERVENTIONAL","TREATMENT",[27],"PHASE4",{"count":29,"type":30},30,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DRUG","Methadone","Methadone 0.2 mg\u002Fkg (max 20 mg)",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Standard of care","Standard intraoperative opioid regimen (control)",[38],[42],{"measure":43,"description":44,"timeFrame":45},"Perioperative Opioid use in morphine equivalents (ME)","perioperative opioid use (morphine equivalents (ME): intraoperative, PACU, and 72-hour totals)","Perioperative until 72 hours postoperative",[47,51,55,59,63,67],{"measure":48,"description":49,"timeFrame":50},"Change in numeric rating scale (NRS) pain scores","Pain scores recorded in the electronic medical record (EMR) using the NRS scale 0-10. A higher score indicates greater pain level. Will track scores over first 24 hours following surgery completion (as determined by PACU arrival)","PACU arrival to 24 hours postoperative",{"measure":52,"description":53,"timeFrame":54},"Time in PACU","Will measure duration of time patient spends in the PACU (measured in hours)","PACU arrival to PACU discharge (determined by time of PACU discharge note entry). Assess up to 24 hours postoperatively.",{"measure":56,"description":57,"timeFrame":58},"Hospital Length of Stay","Duration of time the patient spends in the hospital. Measured in days","Hospital admission to hospital discharge. Measured in days and determined as the time from admission for surgery to hospital discharge. Assess up to 30 days postoperatively",{"measure":60,"description":61,"timeFrame":62},"Incidence of respiratory depression","The incidence of respiratory depression would be defined by any of the following:\n\n* respiratory rate \\\u003C 10 breaths\u002Fmin for \\>5 min\n* SpO₂ \\\u003C 90% for \\>5 min (SpO₂ \\\u003C88% if history of COPD)\n* PaCO₂ \\> 50 mmHg AND increased more than 20% of baseline (if baseline known)\n* Naloxone use postoperatively\n\nThe following events will be documented in the electronic medical record (EMR) and study personnel will chart review for documented incidence of the criteria above and report findings. Will be reported as a \"yes\" or \"no\".","Measured from time of PACU admission until 72 hours postoperatively.",{"measure":64,"description":65,"timeFrame":66},"Incidence of Postoperative nausea and vomiting","Incidence of postoperative nausea or vomiting will be recorded in the electronic medical record (EMR) and study personnel will chart review for documented incidence of postoperative nausea or vomiting during the first 72 hours postoperatively.","Assessed postoperatively up to 72 hours after documented PACU admission time",{"measure":68,"description":69,"timeFrame":70},"Patient Satisfaction","Patient satisfaction survey will be administered by study staff 24 hours postoperatively to measure the patient satisfaction of their postoperative pain management. The survey will measure the following over the 24 postoperatively: the patients pain level on a scale from 1-10, their pain control adequacy from very poorly to very well, functional impact on getting out of bed, walking, deep breathing\u002Fcoughing, physical therapy, sleeping or none, side effects of opioids including: nausea, vomiting, itching, constipation, excessive sleepiness, dizziness, or confusion, and their satisfaction level of pain management from very dissatisfied to very satisfied.","Postoperative until 24 hours postoperative","ALL","18 Years","120 Years",{"inclusion":75,"exclusion":80,"raw_text":84},[76,77,78,79],"Undergoing elective spine surgery (e.g., fusion, decompression)","Expected postoperative inpatient admission","Able to provide informed consent","Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy",[81,82,83],"Use of regional or neuraxial anesthesia","Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease)","Cognitive impairment precluding consent or accurate pain scoring","Inclusion Criteria:\n\n* Undergoing elective spine surgery (e.g., fusion, decompression)\n* Expected postoperative inpatient admission\n* Able to provide informed consent\n* Patients with opioid use disorder (OUD) may be included if on stable maintenance therapy\n\nExclusion Criteria:\n\n* Use of regional or neuraxial anesthesia\n* Contraindication to methadone use (e.g., prolonged QTc, allergy, severe hepatic disease)\n* Cognitive impairment precluding consent or accurate pain scoring",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":101},"University of Kentucky","Lexington","Kentucky","40536","United States",[96],{"name":97,"role":98,"phone":99,"email":100},"Brandon Knopp, MD","CONTACT","859-218-0097","bwkn222@uky.edu",{"lat":102,"lon":103},37.98869,-84.47772,[],[],[],[],{"nct_id":4,"conditions":109,"biomarkers":111},[110],"Pain",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is a prospective cohort study, meaning researchers will follow participants over time. It plans to include 30 participants.","completed","Methadone for Pain After Spine Surgery","This study is looking at whether using methadone after spine surgery can help with pain control and reduce the amount of other pain medications (opioids) you need. Researchers want to see if methadone works as well as or better than the usual pain medication given after surgery. You could be eligible if you are an adult (18-120 years old) having elective spine surgery and expect to stay in the hospital afterward. The study is comparing methadone (0.2 mg\u002Fkg, up to 20 mg) to the standard opioid pain relief given during surgery. The main goal is to measure how much opioid medication is used from surgery until 72 hours (3 days) after.","Your opioid use will be measured from surgery until 72 hours (3 days) after.",111,"Not specified in the trial record.","Not stated in the trial record.",[34],"v2"]