Total Knee Arthroplasty
Conditions
Keywords
pain management, TKA, methadone
Brief summary
The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.
Interventions
DRUGMethadone
Subjects randomized to receive methadone will be given one dose of methadone 0.15mg/kg intravenously dosed based on ideal body weight administered by the anesthesia team prior to surgical incision
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Research staff
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent from 2. Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study. 3. Age 21- 75 4. Unilateral total knee arthroplasty at Colorado Joint Replacement 5. All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment 6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.
Exclusion criteria
1. Narcotic use in the past 6 weeks 2. Current or previous history of drug and alcohol abuse 3. Tobacco use in the previous 90 days 4. Treatment with another investigational drug 5. Patients that cannot receive spinal anesthesia 6. Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)' 7. Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility 8. Obstructive sleep apnea 9. Morbid obesity (BMI \>40) 10. Patients with liver disease. 11. Significant kidney disease - stage 3 CKD or greater 12. Pregnant or nursing females 13. Baseline QTc \>480 14. severe COPD (GOLD 3 or 4) 15. home oxygen requirement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use for 48 hours post-operatively | 48 hours after TKA procedure | Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Defense and Veterans Pain Scale | 2 weeks after TKA procedure | Using the Defense and Veterans Pain Scale, patients will rate their pain ranging from 0 (no pain) to 10 (severe pain) |
| Opioid-Related Symptom Distress Scale (ORSDS) | At baseline and 2 weeks after TKA procedure | 4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4. |
| Pittsburgh Sleep Quality Index | At baseline and 2 weeks after TKA procedure | Patients will complete survey to monitor sleeping habits |
| Total opioid usage over 2 weeks post-operatively | 2 weeks after TKA procedure | Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption. |
| Knee Society Score | At baseline | This survey includes alignment, instability, joint range of motion, and symptoms. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain. |
| KOOS-12 Knee Survey | At baseline | This survey is used to evaluate knee pain, function and quality of life. The total score ranges from 0 to 100, where higher scores indicate better outcomes. |
| Veterans Rand 12-Item Health Survey (VR-12) | At baseline | This survey assesses overall health-related quality of life across physical and mental domains. It generates two summary scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-to provide a standardized evaluation of a patient's functional health and well-being. |
Countries
United States
Contacts
CONTACTMakenna Hemmerle
Outcome results
None listed