NCT07153003

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 opioid consumption, pain, minimize adverse events and complications for primary total knee arthroplasty (TKA) and primary total hip arthroplasty (THA).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for phase_4

Timeline
65mo left

Started Feb 2026

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Sep 2031

First Submitted

Initial submission to the registry

August 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2031

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4.6 years

First QC Date

August 26, 2025

Last Update Submit

March 16, 2026

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption during the first 30 days

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

    30 days

Secondary Outcomes (9)

  • Cumulative opioid consumption during the first 90 days

    90 days

  • Postoperative opioid refills within 90 days

    90 days

  • Number of unused opioid pills

    90 days

  • Change in Visual Analogue Scale (VAS) pain scores

    Daily for 90 days

  • Number of complications

    90 days

  • +4 more secondary outcomes

Study Arms (2)

Oxycodone Only

ACTIVE COMPARATOR

Patient's will be prescribed only Oxycodone for post operative pain management.

Drug: Oxycodone

Multimodal Pain Control

ACTIVE COMPARATOR

Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief.

Drug: Tramadol and Oxycodone

Interventions

OxycodoneDRUG

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

Oxycodone Only
Tramadol and OxycodoneDRUG

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

Multimodal Pain Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary TKA
  • Primary THA
  • Age \> 18 years

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Interventions

OxycodoneTramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Charles P. Hannon, MD, MBA

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 3, 2025

Study Start

February 2, 2026

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2031

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)