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Enrolling by invitation NCT07153003

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

Phase IV Interventional Post Operative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxycodone, Tramadol and Oxycodone.
Who it may be relevant to
Registry conditions: Post Operative Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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).

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 administrati

Primary outcome measures

  • Cumulative opioid consumption during the first 30 days [Time frame: 30 days]
Secondary outcome measures (9)
  • Cumulative opioid consumption during the first 90 days [Time frame: 90 days]
  • Postoperative opioid refills within 90 days [Time frame: 90 days]
  • Number of unused opioid pills [Time frame: 90 days]
  • Change in Visual Analogue Scale (VAS) pain scores [Time frame: Daily for 90 days]
  • Number of complications [Time frame: 90 days]
  • Number of emesis episodes [Time frame: 90 days]
  • Rate of antiemetic use [Time frame: 90 days]
  • Satisfaction survey scores [Time frame: 90 days]
  • Length of Stay [Time frame: Post-operatively, up to 90 days]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07153003 · 25-002295

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗