Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
NCT ID: NCT07153003
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
560 participants
INTERVENTIONAL
2025-12-01
2031-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oxycodone Only
Patient's will be prescribed only Oxycodone for post operative pain management.
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
Multimodal Pain Control
Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief.
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 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
Interventions
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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
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 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
Eligibility Criteria
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Inclusion Criteria
* Primary THA
* Age \> 18 years
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Charles P. Hannon
Principal Investigator
Principal Investigators
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Charles P. Hannon, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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25-002295
Identifier Type: -
Identifier Source: org_study_id