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Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
Sponsor: Mayo Clinic
Summary
The purpose of this study is to evaluate the effectiveness and safety of tramadol and oxycodone therapy in comparison to oxycodone alone as part of a multimodal pain regimen to reduce postoperative opioid consumption, pain, minimize adverse events and complications for primary total knee arthroplasty (TKA) and primary total hip arthroplasty (THA).
Official title: Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty: A Prospective Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
560
Start Date
2026-02-02
Completion Date
2031-09-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Oxycodone
Patients will receive oral Oxycodone only to treat post-operative pain: Oxycodone 5mg * Patients ≤75 years old: 5mg or 10 mg PO every 4 hr as needed * 5 mg for pain rated 4-6 * 10 mg for pain rated 7-10 * Patients \>75 years old and/or sensitive to opioids or sedatives: 2.5mg or 5mg every 4hr as needed * 2.5mg for pain rated 4-6 * 5mg for pain rated 7-10
Tramadol and Oxycodone
Patients will receive a combination of Tramadol and Oxycodone to take orally to treat post-operative pain: Tramadol 50mg * Patients ≤75 years old: 50 mg for pain rated 4-6; 100 mg for pain rated 7-10 * Patients \>75 years old and/or sensitive to opioids or sedatives; use 50 mg * Dosing is every 8 hours as needed. Cumulative dose not to exceed 400mg in 24 hours Oxycodone 5mg * Patients ≤75 years old: 5mg or 10 mg PO every 4 hr as needed if still having pain after maximum tramadol administration * 5 mg for pain rated 4-6 * 10 mg for pain rated 7-10 * Patients \>75 years old and/or sensitive to opioids or sedatives: 2.5mg or 5mg every 4 hr as needed if still having pain after maximum tramadol administration * 2.5 mg for pain rated 4-6 * 5 mg for pain rated 7-10
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States