Dosing of Methadone for Spine Surgery

• ClinicalTrials.gov Identifier: NCT03605901
• Recruitment Status: Completed
• First Posted: July 30, 2018
• Last Update Posted: September 25, 2020
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative	Drug: Standard dosing of methadone; Drug: Aliquots of methadone titrated to apnea	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: Dosing of Methadone for Spine Surgery
• Actual Study Start Date: March 19, 2019
• Actual Primary Completion Date: May 9, 2020
• Actual Study Completion Date: May 9, 2020

Arms and Interventions

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 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 4 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 10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals.

Outcome Measures

Primary Outcome Measures :

1. Change in opioid requirement for complex spine surgery patients [ Time Frame: Changes from baseline (pre-op) up to 72 hours post-op ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patients must consent to participate and sign the Institutional Review Board (IRB) approved informed consent prior to beginning any study specific procedures.
• Undergoing multiple thoracolumbar spine surgery with instrumentation and fusion

Exclusion Criteria:

• History of methadone 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
• History of alcohol abuse
• History of drug abuse
• History of myocardial infarction or heart failure.
• Patients with American Society of Anesthesiologists (ASA) status IV or V

Contacts and Locations

Locations

United States, Florida

UF Health

Gainesville, Florida, United States, 32610-3003

Sponsors and Collaborators

University of Florida

Investigators

• Principal Investigator: Nelson Algarra, MD; University of Florida

More Information

Publications of Results:

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.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT03605901
• Other Study ID Numbers: IRB201700673; OCR18737 ( Other Identifier: University of Florida )
• First Posted: July 30, 2018
• Last Update Posted: September 25, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by University of Florida:

Post-operative pain; Spine surgery; Methadone; Opioid

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Methadone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Antitussive Agents; Respiratory System Agents