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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

NCT07153003 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2026-03-18

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Charles P. Hannon, MD, MBA · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2030-09-01
Completion
2031-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07153003 on ClinicalTrials.gov