Tramadol + Oxycodone for Postoperative Pain

Overseen By Erin Hennessey

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: MOAIs, Benzodiazepines

Disqualifiers: Opioid use disorder, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness and safety of combining tramadol and oxycodone versus using only oxycodone for pain control after hip or knee replacement surgery. Researchers aim to determine if using both drugs can reduce opioid use and lower the risk of side effects. Individuals who have undergone a primary total knee or hip replacement may be suitable candidates, particularly if post-surgery pain management is a concern. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Will I have to stop taking my current medications?

If you are taking Monoamine Oxidase Inhibitors (like phenelzine) or benzodiazepines (like alprazolam), you will need to stop these medications to participate in the trial.

What is the safety track record for tramadol and oxycodone treatments?

Research has shown that using tramadol and oxycodone together can raise safety concerns. Studies have found that tramadol for post-surgery pain can lead to more serious unexpected medical problems compared to oxycodone alone. This indicates a higher risk of complications when combining these two drugs.

One study found that patients taking only oxycodone experienced fewer issues with drowsiness and spent less time in the recovery area after surgery than those taking tramadol. This suggests that oxycodone alone might be easier for the body to handle immediately after surgery.

Overall, while both drugs manage pain, oxycodone on its own might be better tolerated. It's important to weigh the benefits and risks before deciding on the right pain management plan. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for postoperative pain because they offer a potentially more effective pain management strategy. Unlike the standard approach, which often relies solely on oxycodone, the multimodal method combines tramadol with oxycodone. This combination targets pain through different mechanisms, which might enhance pain relief while potentially reducing the risk of side effects associated with higher doses of a single opioid. By utilizing two medications, there's hope for improved pain control and possibly a reduction in the required dosage of each drug, leading to better outcomes for patients recovering from surgery.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare the effectiveness of two postoperative pain management strategies. One group of participants will receive only Oxycodone, while another group will receive a combination of Tramadol and Oxycodone. Research has shown that using both Tramadol and Oxycodone together can effectively manage pain after surgery. Studies have found that Tramadol controls pain as effectively as Oxycodone. However, Tramadol might cause more side effects than Oxycodone alone. Some reviews suggest that while Tramadol and its combinations can significantly reduce pain, they might also increase the risk of side effects. The goal of combining these medications is to lower overall opioid use and reduce complications, which is important for patients recovering from surgeries like knee or hip replacements. ^{3 6 7 8 9}

Who Is on the Research Team?

Charles P. Hannon, MD, MBA

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having their first total knee or hip replacement. It's not for those with a history of opioid use disorder, prior opioid use within the last 3 months, kidney or liver failure, cognitive deficits, pregnancy, breastfeeding, allergies to opioids, or those on certain medications like MOAIs and benzodiazepines.

Inclusion Criteria

I am having or have had my first knee replacement surgery.

I have had a total hip replacement.

I am older than 18 years.

Exclusion Criteria

Prior opioid use disorder/substance use disorder

I am under 18 years old.

I have had a knee or hip replacement revised or partially replaced.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Tramadol and Oxycodone or Oxycodone alone for postoperative pain management

4 weeks

Regular follow-ups as per postoperative care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid consumption

90 days

Daily pain assessments and regular follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• Oxycodone
• Tramadol

Trial Overview The study compares two pain control methods after knee or hip surgery: one group receives Tramadol combined with Oxycodone while the other gets only Oxycodone. The goal is to see which method better reduces pain and opioid need without causing too many side effects.

How Is the Trial Designed?

Group I: Oxycodone Only Active Control 1 Intervention

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

Group II: Multimodal Pain Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-023-02054-8

Oxycodone vs. tramadol in postoperative parent-controlled ... An adequate postoperative analgesia can be achieved with intravenous oxycodone, this with less side effects than tramadol.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07153003

Efficacy And Safety Of Tramadol And Oxycodone Versus ... The purpose of this study is to evaluate the effectiveness and safety of tramadol and oxycodone therapy in comparison to oxycodone alone as part ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X25000157

Tramadol-based multimodal pain protocols after ... Tramadol based pain protocols are equally as effective as oxycodone based pain protocols in controlling post operative pain. •. The Tramadol based cohort ...

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538277/

Tramadol for the Management of Pain in Adult Patients - NCBI Systematic reviews and individual RCTs suggest greater pain reduction and more adverse events with tramadol and tramadol combination products ...

5. cdc.gov cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm

CDC Clinical Practice Guideline for Prescribing Opioids ... The systematic review addressed the effectiveness of long-term opioid therapy for outcomes related to pain, function, and quality of life ...

6. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-04933-2

Comparative safety of tramadol and other opioids following ... Prescribing tramadol for acute postoperative pain was associated with an increased rate of all-cause SAEs compared to oxycodone or hydrocodone.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10155412/

Oxycodone vs. tramadol in postoperative parent-controlled ... However, patients in the oxycodone group showed less sedation levels and had a shorter stay in the PACU, compared with the tramadol group.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0007091217318044

Effect of combining tramadol and morphine in adult ... Our meta-analysis suggests that the addition of tramadol to the analgesic regimen has no effect on pain intensity 24 h after surgery. This is a key point, ...

9. painphysicianjournal.com painphysicianjournal.com/current/pdf?article=NDIxMA==&journal=103

Oral Oxycodone for Acute Postoperative Pain Results showed that pain control was similar in both treatment groups and all patients experienced a reduction in postsurgical pain intensity from day one to ...