Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA
- Conditions
- Osteoarthritis (OA) of the Knee
- Interventions
- Drug: Preoperative MethadoneDrug: Preoperative Oxycodone
- Registration Number
- NCT06691633
- Lead Sponsor
- University of Louisville
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- History of liver or kidney disease,
- Known or suspected GI obstruction
- Hypersensitivity to methadone
- Patients with significant respiratory depression
- Pregnant or nursing females
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methadone Group Preoperative Methadone Participant receives a one-time preoperative dose of 10 mg of methadone Oxycodone Group Preoperative Oxycodone participant receives a one-time preoperative dose of 10 mg of oral oxycodone
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Hospital Length of Stay Up to 2 weeks Number of days patient was an inpatient in the hospital prior to discharge date
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
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.
Trial Locations
- Locations (1)
UofL Health
🇺🇸Louisville, Kentucky, United States