What this study is
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).
What's being tested
- Oxycodone
Intervention · 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
Intervention · 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
- 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
- Sponsor
- Mayo Clinic
- Conditions
- Post Operative Pain
- Enrolling
- 560 people
- Starts
- 2026-02-02
- Est. completion
- 2031-09-01
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Primary TKA
- Primary THA
- Age > 18 years
You can't join if
- Age < 18 years
- Revision or partial TKA/THA
- Pregnant or breast-feeding women
- Simultaneous bilateral TKA/THA
- Primary TKA/THA due to oncologic reason
- Anaphylaxis to opioids
- Renal or liver failure
- Prior opioid use disorder/ substance use disorder
- Opioid use within 3 months prior to surgery
- Patients needing a translator and those with dementia or other cognitive deficits
- Patients taking Monoamine Oxidase Inhibitor (MOAI) medications (phenelzine, tranylcypromine) or benzodiazepine medications (alprazolam, diazepam, lorazepam, etc)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openMayo Clinic in Rochester
Rochester, Minnesota, United States
Study team
Sponsor
Mayo Clinic
Study ID 25-002295
Principal investigator
Charles P. Hannon, MD, MBA
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.