Dosing of Methadone for Spine Surgery

NCT03605901 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: IRB201700673OCR18737
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two methods of dosing methadone for complex spine cases

Conditions

Pain, Postoperative

Keywords

Post-operative pain; Spine surgery; Methadone; Opioid

Outcome Measures

Primary Outcomes (1)

• Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop

  The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline).

  Postop 24 hours, Postop 48 hours, Postop 72 hours

Study Arms (2)

Standard dosing of methadone

ACTIVE COMPARATOR

Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.

Drug: Standard dosing of methadone

Aliquots of methadone titrated to apnea

EXPERIMENTAL

Receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals. The practitioner will continue to coach patient to take deep breaths. After reaching the apnea threshold as determined by respiratory rate less than 8 breaths/min, induction of general anesthesia and intubation will proceed.

Drug: Aliquots of methadone titrated to apnea

Interventions

Standard dosing of methadone DRUG

Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.

Standard dosing of methadone

Aliquots of methadone titrated to apnea DRUG

Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 5-10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals.

Aliquots of methadone titrated to apnea

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must consent to participate and sign the IRB-approved informed consent prior to beginning any study specific procedures.
• At or between the ages 18 to 75 years.
• Undergoing multilevel thoracic, thoracolumbar and/or lumbar spine surgery with instrumentation and fusion.

You may not qualify if:

• Methadone or buprenorphine use.
• Morbid obesity with BMI\>40 Kg/m2.
• Chronic renal failure with creatinine\>2.0 mg/dL.
• Liver failure as determined by cirrhosis or history of fulminant hepatic failure.
• Current or historical alcohol abuse.
• Current or historical drug abuse.
• Patients with history of prolonged QTc, as defined as a QTc value \>450 ms in males and \>460 ms in females.
• Patients with ASA status IV or V.
• Surgical diagnosis including spine tumor, infection, or trauma.
• In the Principal Investigator's opinion is not a candidate for the study.
• Unwilling to sign the informed consent form.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health

Gainesville, Florida, 32610-3003, United States

Location

Related Publications (1)

• Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

  PMID: 20418538 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Cynthia Garvan
• Organization: University of Florida

cgarvan@ufl.edu

352-870-5403

Study Officials

• Christoph Seubert, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Post-operative data will be collected by blinded staff. Patient daily pain based on the analog scale of 0-10 post-operative for the first 72 hours, total opioid usage, length of stay, time to get out of bed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomly assigned to one of two different protocols by a designated study team member based on a computer generated randomization table. Randomization will occur on the day of surgery. Randomization will be 1:1.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: July 30, 2018
• Study Start: March 19, 2019
• Primary Completion: May 9, 2025
• Study Completion: May 9, 2025
• Last Updated: June 23, 2026
• Results First Posted: June 23, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)