Osteoarthritis (OA) of the Knee
Conditions
Keywords
osteoarthritis, knee, total knee arthroplasty, prospective RCT, preoperative analgesia, Methadone
Brief summary
The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA. The main questions it aims to answer are: * What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty? * Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty Participants will: * be randomized into one of two groups * undergo a primary TKA * complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA * return to office at 2 weeks and 6 weeks postop for follow-up * complete additional questionnaires at 2 weeks and 6 weeks postop
Interventions
DRUGPreoperative Methadone
patient receives a one-time preoperative dose of 10 mg of methadone
DRUGPreoperative Oxycodone
patient receives a one-time preoperative dose of 10 mg of oral oxycodone
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Clinical staff other than the anesthesia providers
Intervention model description
Prospective, randomized cohort analysis study
Eligibility
Sex/Gender
ALL
Age
21 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
1. Patient age is 21-89 at time of surgery 2. Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis 3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document 4. Patient is able to read and speak English.
Exclusion criteria
1. Patient is under the age of 21 2. Patient's primary diagnosis is not osteoarthritis 3. Patient is unable to read and speak English 4. History of liver or kidney disease, 5. Known or suspected GI obstruction 6. Hypersensitivity to methadone 7. Patients with significant respiratory depression 8. Pregnant or nursing females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Opioid Use | 2 weeks | Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA |
| Total opioid usage over two weeks | 2 weeks | total daily opioid usage (as measured in MME) during the first 14 days following TKA |
| Visual Analogue Scale pain score | 2 weeks | Visual Analogue Scale knee pain score (minimum value: 0, maximum value: 10). Higher scores equate to a worse outcome (a score of zero = pain free). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score | preoperatively and 6 weeks (± 2 weeks) postoperatively | The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR.) is a survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. The minimum value is 0, the maximum value is 100. A higher score means a better outcome. |
| Hospital Length of Stay | Up to 2 weeks | Number of days patient was an inpatient in the hospital prior to discharge date |
| ROM | preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively | active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion |
| Discharge location | 2 weeks | Whether patient was discharged to home or to a rehab facility |
| Two and six-week narcotic refill | 6 weeks | Whether patient was prescribed a two week and/or six-week postoperative narcotic refill |
Countries
United States
Outcome results
None listed