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

Spine Surgery Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05693675
• Other study ID #: HSC-MS-22-0912
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Shobana Rajan, MD
• Phone: 713-500-6200
• Email: Shobana.Rajan[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults undergoing multilevel complex lumbar and/or thoracic spine fusion surgery, including revision surgeries

Exclusion Criteria:

• BMI greater than 40

Related Conditions & MeSH terms

• Spine Surgery

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Feasibility of study design as assessed by number of participants for which safety was able to be assessed (EKGs)		postop days 1 and 5
Primary	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	Day of discharge (about 6 days after surgery)
Primary	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	Number of participants for which opioid usage was able to be collected		Day of discharge (about 6 days after surgery)
Secondary	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.	by fifth day of hospital stay
Secondary	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	by fifth day of hospital stay
Secondary	Safety as assessed by the number of participants with hallucinations		by fifth day of hospital stay
Secondary	Safety as assessed by the number of participants with dizziness		by fifth day of hospital stay
Secondary	Safety as assessed by the number of participants with Antiemetic use		by fifth day of hospital stay
Secondary	Safety as assessed by the number of participants with occurrence of nausea		by fifth day of hospital stay
Secondary	Safety as assessed by the number of participants with occurrence of vomiting		by fifth day of hospital stay
Secondary	Safety as assessed by the number of participants with occurrence of Ileus or constipation		by fifth day of hospital stay
Secondary	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)	3 months after surgery