Pain, Postoperative
Conditions
Keywords
Post-operative pain, Spine surgery, Methadone, Opioid
Brief summary
This study compares two methods of dosing methadone for complex spine cases
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.
Interventions
DRUGStandard dosing of methadone
Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
DRUGAliquots 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.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Opioid Requirement for Complex Spine Surgery Patients 24, 48, and 72 Hours Postop | Postop 24 hours, Postop 48 hours, Postop 72 hours | The milligram morphine equivalence (MME) dose was computed for each patient in each 24 hour period using IV (intravenous) administration and by mouth (PO). The outcome measure is defined as the difference between 24 hour periods in the cumulative morphine milligram equivalence dose across both IV (intravenous) administration and by mouth (PO). The difference was calculated by subtracting the MME dose value at the later time point minus the MME value at the earlier time point (e.g., value at 24 hours postop minus value at baseline). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristoph Seubert, MD
University of Florida
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 11.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 11 |
Outcome results
None listed