Ibuprofen & Acetaminophen vs Oxycodone for Postoperative Pain

Recruiting at 1 trial location

Overseen By Amy Ladd, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Opioids

Disqualifiers: Pregnancy, Liver dysfunction, Heart 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

121 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores better ways to manage pain after thumb surgery for osteoarthritis. Researchers aim to determine if a combination of over-the-counter drugs, ibuprofen and acetaminophen (NSAID combo capsule), can effectively control pain like oxycodone, a prescription opioid, but without the risk of addiction. Participants will be divided into two groups: one taking the non-narcotic medications and the other taking oxycodone, with each group providing feedback through surveys. Those who have had thumb surgery for osteoarthritis and do not currently use opioids might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using opioids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking ibuprofen and acetaminophen together for pain relief is generally safe. Studies often find that this combination can relieve pain as well as or better than some opioid medications, making it a strong but safer option for managing pain.

Studies have demonstrated that oxycodone effectively treats sudden pain after surgery. However, it can cause side effects like nausea and vomiting, which are common with many opioids. Long-term use of opioids can also lead to addiction.

The trial under consideration is in an early stage, focusing mainly on safety and how the treatments work in people. Safety is a top priority, but some risks might still be unknown.

Overall, the ibuprofen and acetaminophen combination has a good safety record, while oxycodone is effective but may have more side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for postoperative pain because they explore different approaches to pain management. The NSAID combo capsule combines ibuprofen and acetaminophen, which are non-opioid pain relievers known for reducing inflammation and pain without the risk of addiction associated with opioids like oxycodone. This treatment offers a potentially safer alternative by minimizing the side effects and dependency risks that come with traditional opioid use. Meanwhile, opioids remain effective for severe pain but come with a higher risk profile. By comparing these approaches, researchers hope to identify safer and more effective ways to manage pain after surgery.

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

This trial will compare the effectiveness of NSAID capsules (a combination of ibuprofen and acetaminophen) with opioid capsules (such as oxycodone) for postoperative pain management. Studies have shown that combining ibuprofen and acetaminophen effectively relieves pain. Research suggests this combination can match or even surpass opioids in managing pain. For instance, a study from Rutgers found that this combo provided better pain relief than opioids after dental surgery. It is also considered safer, as it doesn't carry the addiction risks associated with opioids. While oxycodone is a strong painkiller, it may not always offer better relief than the ibuprofen and acetaminophen combo. Although effective, oxycodone's potential for addiction and side effects can be concerning. ^{1 2 3 4 6}

Who Is on the Research Team?

Amy Ladd, MD

Principal Investigator

Stanford Orthopaedic Surgery

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals undergoing trapeziectomy due to thumb osteoarthritis. It's not suitable for those with concurrent surgeries, liver/kidney issues, allergies to the study medications, pregnant women, people unable to complete forms due to various conditions, or patients with a history of heart failure, bleeding disorders or current opioid use.

Inclusion Criteria

English proficient

I am having surgery for thumb arthritis.

Exclusion Criteria

I cannot use common pain relievers due to liver or kidney issues.

I am currently using opioids.

Inability to complete study forms (education, cognitive ability, mental status, medical status)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either NSAIDs (ibuprofen and acetaminophen) or opioids (oxycodone) for pain management after trapeziectomy surgery

4 weeks

Daily monitoring through online and phone surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post-operative weeks 1, 3, 5, and 8 assessments

What Are the Treatments Tested in This Trial?

Interventions

• NSAID capsules
• NSAID combo capsule
• Opioid capsule

Trial Overview The study compares pain management strategies post-trapeziectomy: one group receives NSAIDs (ibuprofen and acetaminophen) while the other gets an opioid (oxycodone). The goal is to assess if non-narcotic meds can effectively manage pain without using opioids in the first month after surgery.

How Is the Trial Designed?

Group I: Opioids Experimental Treatment 1 Intervention

Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.

Group II: NSAIDS Experimental Treatment 1 Intervention

Following surgery will receive NSAID capsules following surgery. Will take online and phone surveys.

NSAID combo capsule is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ibuprofen & Acetaminophen combo for:

• Pain relief
• Fever reduction
• Inflammation

Approved in European Union as Ibuprofen & Acetaminophen combo for:

• Pain relief
• Fever reduction
• Inflammation

Approved in Canada as Ibuprofen & Acetaminophen combo for:

• Pain relief
• Fever reduction
• Inflammation

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Combining analgesic drugs, such as oxycodone with acetaminophen or nonsteroidal anti-inflammatory drugs, may provide better pain relief and fewer side effects compared to using each drug alone, although more research is needed to confirm this.

Current clinical experience suggests that these combinations are generally safe and effective, but it is crucial to evaluate their adverse effect profiles to ensure a proper benefit/risk assessment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxycodone combinations for pain relief. Raffa, RB., Pergolizzi, JV., Segarnick, DJ., et al.[2023]

In a study of 61 patients undergoing anterior cruciate ligament reconstruction, ibuprofen (800 mg) was found to significantly reduce pain more effectively than acetaminophen (1 g) during the first 6 hours post-surgery.

The combination of ibuprofen and acetaminophen did not show any additional benefits in pain relief compared to ibuprofen alone, and both treatments had similar safety profiles with no significant differences in side effects or renal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen vs. acetaminophen vs. ibuprofen and acetaminophen after arthroscopically assisted anterior cruciate ligament reconstruction. Dahl, V., Dybvik, T., Steen, T., et al.[2019]

In a study of 120 patients experiencing pain after wisdom tooth removal, the combination of 100-mg enteric-coated diclofenac and 1 g acetaminophen provided superior pain relief compared to other treatments, including acetaminophen alone or acetaminophen with codeine.

The addition of codeine increased side effects without providing additional pain relief benefits, highlighting that the diclofenac and acetaminophen combination is a safer and more effective option for managing acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining diclofenac with acetaminophen or acetaminophen-codeine after oral surgery: a randomized, double-blind single-dose study. Breivik, EK., Barkvoll, P., Skovlund, E.[2020]

The new oxycodone 10-mg/acetaminophen 325-mg formulation (Percocet) was found to be more effective than a higher dose of oxycodone alone in managing acute pain after oral surgery, based on a study of 141 patients.

This combination not only provided faster pain relief but also resulted in fewer treatment-related side effects, highlighting its potential as a safer alternative for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. Gammaitoni, AR., Galer, BS., Bulloch, S., et al.[2019]

A combination of hydrocodone 7.5 mg and ibuprofen 200 mg was found to be as effective as a combination of oxycodone 5 mg and acetaminophen 325 mg for treating moderate to severe postoperative pain, based on a study involving 120 participants.

Both treatment combinations provided significantly better pain relief compared to placebo, with hydrocodone and ibuprofen showing greater effectiveness at later time points (5, 6, and 8 hours) after administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain. Palangio, M., Wideman, GL., Keffer, M., et al.[2019]

A single-tablet combination of ibuprofen 200mg and paracetamol 500mg was found to be highly effective for pain relief in patients with moderate to severe postoperative pain, outperforming both placebo and paracetamol/codeine combinations.

The combination of ibuprofen and paracetamol also had fewer adverse events compared to codeine combinations, indicating a safer profile while providing comparable or superior analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, five-parallel-group, placebo-controlled trial comparing the efficacy and tolerability of analgesic combinations including a novel single-tablet combination of ibuprofen/paracetamol for postoperative dental pain. Daniels, SE., Goulder, MA., Aspley, S., et al.[2022]

A systematic review of five randomized controlled trials found that combining non-selective NSAIDs with paracetamol provides significantly better pain relief after oral surgery compared to using either drug alone.

While mild to moderate adverse events like nausea and headache were reported across treatment groups, the combination of ibuprofen and paracetamol showed fewer side effects compared to ibuprofen alone, suggesting it could be a safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The combination of non-selective NSAID 400 mg and paracetamol 1000 mg is more effective than each drug alone for treatment of acute pain. A systematic review. Alexander, L., Hall, E., Eriksson, L., et al.[2018]

In a study involving 238 patients with pain from abdominal gynecologic surgery, bromfenac (50 or 100 mg) provided pain relief that was at least as effective as acetaminophen/oxycodone, but with a longer duration of action.

Bromfenac also resulted in a lower rate of remedication compared to acetaminophen/oxycodone and ibuprofen, which was found to be less effective overall.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain. Johnson, GH., Van Wagoner, JD., Brown, J., et al.[2019]

Multimodal analgesic combinations, which include fixed-dose combinations of analgesics like acetaminophen, aspirin, and ibuprofen, can improve pain relief while minimizing adverse effects, making them effective for managing pain of various origins.

There is a need for ongoing research to determine the best combinations and dosages of analgesics tailored to individual patients to achieve optimal pain relief and reduce the risk of adverse drug interactions, especially considering the common use of over-the-counter medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acetaminophen, aspirin, or Ibuprofen in combination analgesic products. Barkin, RL.[2020]

NSAIDs are generally more effective than paracetamol for pain relief in dental surgery, while their effectiveness is similar in major and orthopedic surgeries, indicating that the choice of pain management may depend on the type of surgery.

Paracetamol is a safer alternative to NSAIDs due to its lower incidence of adverse effects, making it a preferred option for high-risk patients; combining paracetamol with NSAIDs may enhance pain relief, but more research is needed to assess potential side effects from this combination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. Hyllested, M., Jones, S., Pedersen, JL., et al.[2022]

In a study involving 57 patients after root canal treatment, the combination of ibuprofen and acetaminophen provided significantly better pain relief compared to either ibuprofen alone or a placebo.

There was no significant difference in pain relief between the placebo and ibuprofen alone, indicating that the combination therapy is more effective for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Menhinick, KA., Gutmann, JL., Regan, JD., et al.[2022]

Ibuprofen is an effective and safe option for managing mild to moderate postoperative pain, as demonstrated in controlled clinical trials.

In a study involving 120 patients with postoperative orthopedic pain, ibuprofen outperformed acetaminophen-codeine in effectiveness and provided longer-lasting relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. Slavic-Svircev, V., Heidrich, G., Kaiko, RF., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2791549/

Combined acetaminophen and ibuprofen for pain relief after ... Maxigesic tablets provide superior pain relief after oral surgery to acetaminophen or ibuprofen alone.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7419400/

Evaluation of Fixed-Dose Combinations of Ibuprofen and ... The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and ...

3. haleonhealthpartner.com haleonhealthpartner.com/content/dam/cf-consumer-healthcare/health-professionals/en_US/pdf/Ibuprofen-Acetaminophen-Combo-for-Pain-Management-Study.pdf

Ibuprofen/acetaminophen fixed-dose combination as an ... Across studies, IBU/APAP. FDCs consistently demonstrated pain relief similar to or better than opioid and nonopioid comparators and reliably ...

4. floridahealth.gov floridahealth.gov/statistics-and-data/e-forcse/news-reports/_documents/evidence-efficacy-pain-medications.pdf

Evidence for the efficacy of pain medications • Ibuprofen 200 mg + acetaminophen 500 mg: The combination of these two OTC medicines provided the best pain relief of all, with an NNT of 1.6. (CJ Derry ...

5. scitechdaily.com scitechdaily.com/study-reveals-tylenol-and-advil-outperform-opioids-for-wisdom-tooth-pain/

Study Reveals Tylenol and Advil Outperform Opioids for ... A Rutgers study shows acetaminophen and ibuprofen outperform opioids for pain relief after wisdom tooth removal, leading to better outcomes ...

6. bmcemergmed.biomedcentral.com bmcemergmed.biomedcentral.com/articles/10.1186/s12873-024-00933-y

Comparing the efficacy of intravenous morphine versus ... The study findings suggest that ibuprofen and its combination with acetaminophen have similar or better analgesic effects compared to morphine in patients with ...