Status:
NOT_YET_RECRUITING
Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
Lead Sponsor:
Mayo Clinic
Conditions:
Post Operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 op...
Eligibility Criteria
Inclusion
- Primary TKA
- Primary THA
- Age \> 18 years
Exclusion
- 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)
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2031
Estimated Enrollment :
560 Patients enrolled
Trial Details
Trial ID
NCT07153003
Start Date
December 1 2025
End Date
September 1 2031
Last Update
November 12 2025
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905