Dosing of Methadone for Spine Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Standard dosing of methadone; Drug: Aliquots of methadone titrated to apnea

Detailed Description

Patients with spine surgery experience a significant amount of pain that can interfere with healing, rehabilitation and contribute to morbidity in the post-operative period. This study will compare post-operative opioid requirement at 24 and 48 hours to determine if methadone given in small aliquots until respiratory depression can act as a self-control to determine the correct dose required.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Amy M Gunnett, RN, CCRC; Phone Number: 352-273-8911; Email: agunnett@anest.ufl.edu
• Study Contact Backup: Name: Regina Knudsen, MS; Phone Number: 3522736786; Email: rknudsen@anest.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610-3003
      • Recruiting
      • UF Health
      • Contact: Amy M Gunnett; Phone Number: 352-273-8911; Email: agunnett@anest.ufl.edu
      • Contact: Basma Mohamed, MD; Email: bmohamed@anest.ufl.edu
      • Principal Investigator: Basma Mohamed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard dosing of methadone; Receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.	Drug: Standard dosing of methadone; Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
Experimental: Aliquots of methadone titrated to apnea; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in opioid requirement for complex spine surgery patients	Titrating methadone to respiratory depression allows the patient to act as his own control determining the dose he will require, improving pain control and consequently decreasing side effects and complications.	Changes from baseline (pre-op) up to 72 hours post-op

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Basma Mohamed, MD, University of Florida

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2019
• Primary Completion (Anticipated): May 9, 2024
• Study Completion (Anticipated): May 9, 2024

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Opioid; Methadone; Post-operative pain; Spine surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: IRB201700673; OCR18737 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No