Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months
- Conditions
- Spine Surgery
- Interventions
- Registration Number
- NCT05693675
- Brief Summary
The purpose of this study is to evaluate the feasibility and safety of a clinical protocol based on the administration of intraoperative intravenous methadone followed by a short regimen of oral/IV (if the patient is not able to take oral) methadone following spine surgery and to evaluate if methadone decreases persistent opioid usage at 3 months in comparison to placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 30
- Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries
- BMI greater than 40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Postoperative methadone Postoperative methadone - Postoperative methadone Rescue Analgesia - Postoperative placebo Postoperative placebo - Postoperative placebo Rescue Analgesia -
- Primary Outcome Measures
Name Time Method Feasibility of study design as assessed by the number of participants for which scheduled postoperative methadone versus placebo were able to be administered according to the scheme described Day of discharge (about 6 days after surgery) Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs) postop days 1 and 5 Feasibility of study design as assessed by the number of participants for which safety was able to be assessed (respiratory events) Day of discharge (about 6 days after surgery) ability to evaluate adverse respiratory events
Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months 3 months after surgery
- Secondary Outcome Measures
Name Time Method Safety as assessed by the number of participants with dizziness by fifth day of hospital stay Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation by fifth day of hospital stay QTc interval \>500ms or \>25% increase from baseline; number of patients developing arrhythmias needed treatment
Safety as assessed by the number of participants with occurrence of nausea by fifth day of hospital stay Number of participants for which opioid usage was able to be collected Day of discharge (about 6 days after surgery) Safety as assessed by the number of participants with hallucinations by fifth day of hospital stay Safety as assessed by the number of participants with Antiemetic use by fifth day of hospital stay Safety as assessed by the number of participants with occurrence of vomiting by fifth day of hospital stay Safety as assessed by the number of patients developing respiratory depression by fifth day of hospital stay Saturation of Oxygen(SPO2) less than 85%, Respiratory rate \<5 for longer than 3 minutes, ( Khanna et) increased oxygen requirement related to opioid-induced respiratory depression, naloxone use. The SPO2 will be monitored continuously per usual care in post anesthesia care unit (PACU) and every 4 hours in the ward.
Safety as assessed by the number of subjects with persistent opioid use 3 months after surgery This is scored from 0(less than once a week) to 4(constantly, a higher number indicating more opioid use)
Safety as assessed by the number of participants with occurrence of Ileus or constipation by fifth day of hospital stay
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States