Dosing of Methadone for Spine Surgery

Pain, Postoperative Clinical Trial

Official title:

Dosing of Methadone for Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03605901
• Other study ID #: IRB201700673
• Secondary ID: OCR18737
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 19, 2019
• Est. completion date: May 9, 2024

Study information

• Verified date: May 2023
• Source: University of Florida
• Contact: Amy M Gunnett, RN, CCRC
• Phone: 352-273-8911
• Email: agunnett[@]anest.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 9, 2024
• Est. primary completion date: May 9, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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