Post Operative PainPhase 4NCT07153003
Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
A Phase 4 study testing Oxycodone and Tramadol and Oxycodone in people with Post Operative Pain, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Oxycodone and Tramadol and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 1 Sep 2031
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary TKA
- Primary THA
- Age > 18 years
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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).
- Conditions
- Post Operative Pain
- Being tested
- Oxycodone, Tramadol and Oxycodone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Only | Active comparator | Patient's will be prescribed only Oxycodone for post operative pain management. Receives: Drug: Oxycodone |
| Multimodal Pain Control | Active comparator | Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief. Receives: Drug: Tramadol and Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (9)
Cumulative opioid consumption during the first 90 days
Total amount of opioid medication taken for the first 90 days following surgery, reported in milligrams (mg)
Measured: 90 days
Postoperative opioid refills within 90 days
Total number of opioid medication refills within 90 days post surgery
Measured: 90 days
Number of unused opioid pills
Total number of unused opioid pills unused after 90 days
Measured: 90 days
Change in Visual Analogue Scale (VAS) pain scores
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.
Measured: Daily for 90 days
Number of complications
Total number of complications experienced post-operatively, complications include stiffness, VTE, GI hemorrhage, falls, ileus, dizziness, changes in vision, and miosis.
Measured: 90 days
Number of emesis episodes
Postoperative nausea and vomiting will be measured by total number of emesis episodes
Measured: 90 days
Rate of antiemetic use
Total number of times patients require use of antiemetics for nausea or vomiting
Measured: 90 days
Satisfaction survey scores
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.
Measured: 90 days
Length of Stay
Total number of days patients stay inpatient
Measured: Post-operatively, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start2 Feb 2026
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles P. Hannon, Mayo Clinic
- Investigators
- Charles P. Hannon, MD, MBA, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153003
- Sponsor's protocol ID
- 25-002295
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07153003
- Acronym / sponsor ID
- 25-002295
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Only | Active comparator | Drug: OxycodonePatient's will be prescribed only Oxycodone for post operative pain management. |
| Multimodal Pain Control | Active comparator | Drug: Tramadol and OxycodonePatients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary TKA
- Primary THA
- Age > 18 years
Key exclusion criteria (11 listed)
- Age < 18 years
- Revision or partial TKA/THA
- Pregnant or breast-feeding women
- Simultaneous bilateral TKA/THA
- Primary TKA/THA due to oncologic reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodonePatients 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 | Oxycodone Only |
| Tramadol and OxycodonePatients 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 | Drug | Multimodal Pain Control |
Primary outcome
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)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles P. Hannon, MD, MBA principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone and Tramadol and Oxycodone in people with Post Operative Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption during the first 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.