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Enrolling by Invitation

NCT Number: NCT07153003

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

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).

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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)

Treatment and study plan

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

Primary outcomes

  1. Cumulative opioid consumption during the first 30 days

    Time frame: 30 days

    Total amount of opioid medication taken for the first 30 days following surgery, reported in milligrams (mg)

Secondary outcomes

  1. Cumulative opioid consumption during the first 90 days

    Time frame: 90 days

    Total amount of opioid medication taken for the first 90 days following surgery, reported in milligrams (mg)

  2. Postoperative opioid refills within 90 days

    Time frame: 90 days

    Total number of opioid medication refills within 90 days post surgery

  3. Number of unused opioid pills

    Time frame: 90 days

    Total number of unused opioid pills unused after 90 days

  4. Change in Visual Analogue Scale (VAS) pain scores

    Time frame: Daily for 90 days

    Pain values reported by participants will be assessed using the 100-mm Visual Analogue Scale (VAS). The VAS line will be 100 mm long with no intermediate delineations. Each end will be marked with "no pain" on the left, and "worst possible pain" on the right. Participants will identify their pain level by indicating a point on the line between each end. That point will be measured from the "No pain" end, and the number of millimeters will be reported as the pain score.

  5. Number of complications

    Time frame: 90 days

    Total number of complications experienced post-operatively, complications include stiffness, VTE, GI hemorrhage, falls, ileus, dizziness, changes in vision, and miosis.

  6. Number of emesis episodes

    Time frame: 90 days

    Postoperative nausea and vomiting will be measured by total number of emesis episodes

  7. Rate of antiemetic use

    Time frame: 90 days

    Total number of times patients require use of antiemetics for nausea or vomiting

  8. Satisfaction survey scores

    Time frame: 90 days

    Patients will be provided with a satisfaction survey 90 days post-surgery. The survey consists of 2 questions rated on a Likert scale measuring understanding and confidence in medication use, and one yes/no question. The Likert scale questions are ranked from "0" - no understanding/low confidence to "10" - full understanding/high confidence. Higher scores indicate greater satisfaction with the prescribed opioid therapy plan.

  9. Length of Stay

    Time frame: Post-operatively, up to 90 days

    Total number of days patients stay inpatient

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 3, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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