NCT06691633

Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA

Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis (OA) of the Knee

Interventions

Type	Name	Description
DRUG	Preoperative Methadone	patient receives a one-time preoperative dose of 10 mg of methadone
DRUG	Preoperative Oxycodone	patient receives a one-time preoperative dose of 10 mg of oral oxycodone

Timeline

• Start date: 2024-02-19
• Primary completion: 2024-09-24
• Completion: 2024-10-18
• First posted: 2024-11-15
• Last updated: 2024-11-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study