Dosing of Methadone for Spine Surgery

University of Florida

Status and phase: Terminated; Phase 2

Conditions: Pain, Postoperative

Treatments: Drug: Aliquots of methadone titrated to apnea; Drug: Standard dosing of methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT03605901

OCR18737 (Other Identifier)

IRB201700673

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Standard dosing of methadone

Active Comparator group

Description:

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

Treatment:

Drug: Standard dosing of methadone

Aliquots of methadone titrated to apnea

Experimental group

Description:

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.

Treatment:

Drug: Aliquots of methadone titrated to apnea