Dosing of Methadone for Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-19

Study Completion Date

2025-05-09

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Standard dosing of methadone

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

Group Type ACTIVE_COMPARATOR

Standard dosing of methadone

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Aliquots of methadone titrated to apnea

Intervention Type 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.

Interventions

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Standard dosing of methadone

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No