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

Overview

About this study

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).
We hypothesize that for patients undergoing primary TKA or THA, the use of a combined tramadol and oxycodone therapy as part of a multimodal pain regimen will provide greater pain relief and less opioid consumption within 90 days after surgery without an increase in adverse events as compared to patients receiving oxycodone alone.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Primary TKA

  • Primary THA

  • Age > 18 years

Exclusion Criteria:

  • 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)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/19/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Hannon, M.D., M.B.A.

Contact us for the latest status

Contact information:

Gabriel Schouten

(507) 266-5895

Schouten.Gabriel@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20588156

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