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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07153003
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Post Operative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxycodone — DRUG
    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 — DRUG
    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

Study Details

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).

Key Dates

Start date
Feb 2, 2026
Status verified
Mar 2026
Primary completion
Sep 1, 2030
Completion
Sep 1, 2031

Study Design

Enrollment
560 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Oxycodone Only
    Patient's will be prescribed only Oxycodone for post operative pain management.
  • Active Comparator: Multimodal Pain Control
    Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief.

Primary Outcome Measure

Cumulative opioid consumption during the first 30 days [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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By research site
Mayo Clinic in Rochester· Rochester, MN

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