NCT07153003

Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty

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

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2026-02-02
• Primary completion: 2030-09-01
• Completion: 2031-09-01
• First posted: 2025-09-03
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study