A Phase 2/3 interventional study of Postoperative methadone and Postoperative placebo in Spine Surgery, sponsored by The University of Texas Health Science Center, Houston. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2/3, Interventional, and Treatment
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.
The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Postoperative methadone · Drug: Rescue Analgesia
Drug: Postoperative placebo · Drug: Rescue Analgesia
Participants will receive intraoperative methadone (0.2 mg/kg ideal body weight intravenously but not exceeding 20mg) followed by oral/IV methadone postoperatively according to the following scheme: A) Opioid naïve patients will receive 5mg twice daily dosage of methadone on postoperative days 1 and 2 followed by 5 mg daily on postoperative days 3, 4, and 5. B) Patients taking opioids preoperatively will continue to receive their regular opioids and additionally receive 5 mg twice a day of methadone on postoperative days 1 and 2, followed by 5 mg per day on days 3, 4 and 5.
Participants will receive intraoperative methadone intravenously 0.2mg/kg followed by oral placebo postoperatively according to the following scheme: Opioid naïve patients and patients taking opioids preoperatively will receive placebo tablets twice daily on day 1 and day 2 and once daily day 3, 4 and 5. Patients taking preoperative opioids will be able to return to their baseline opioids immediately after surgery.
PACU analgesia for both groups will be the usual care regime of fentanyl or hydromorphone bolus as prescribed by the physician anesthesiologist doing the case. All patients receive IV intravenous patient-controlled analgesia and rescue opioids which is usual care for postoperative pain.
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
Time frame: 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)
Time frame: 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)
ability to evaluate adverse respiratory events
Time frame: Day of discharge (about 6 days after surgery)
Feasibility of study design as assessed by the number of participants for which postop opioid usage could be surveyed at 3 months
Time frame: 3 months after surgery
Number of participants for which opioid usage was able to be collected
Time frame: Day of discharge (about 6 days after surgery)
Safety as assessed by the number of patients developing respiratory depression
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.
Time frame: by fifth day of hospital stay
Safety as assessed by the number of patients developing clinically significant corrected QT interval(QTc )prolongation
QTc interval \>500ms or \>25% increase from baseline; number of patients developing arrhythmias needed treatment
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with hallucinations
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with dizziness
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with Antiemetic use
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of nausea
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of vomiting
Time frame: by fifth day of hospital stay
Safety as assessed by the number of participants with occurrence of Ileus or constipation
Time frame: by fifth day of hospital stay
Safety as assessed by the number of subjects with persistent opioid use
This is scored from 0(less than once a week) to 4(constantly, a higher number indicating more opioid use)
Time frame: 3 months after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The University of Texas Health Science Center, Houston