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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
The University of Texas Health Science Center at Houston
Houston, Texas, United States
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
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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.
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