NCT05693675

Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months

Postoperative Oral Methadone After Major Spine Surgery; Safety, Feasibility and Efficacy in Prevention of Progression to Chronic Opioid Usage at 3 Months - A Pilot Trial.

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spine Surgery

Interventions

Type	Name	Description
DRUG	Postoperative methadone	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.
DRUG	Postoperative placebo	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.
DRUG	Rescue Analgesia	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.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-01-23
• Last updated: 2025-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study