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

Trial Summary

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.

What data supports the effectiveness of the drug combination of ibuprofen and acetaminophen for postoperative pain?

Research shows that combining ibuprofen and acetaminophen can provide more effective pain relief than using either drug alone, as seen in studies involving root canal treatment and orthopedic surgery. This combination offers enhanced pain control with fewer side effects compared to higher doses of a single drug. ^{1 2 3 4 5}

Is the combination of ibuprofen, acetaminophen, and oxycodone safe for postoperative pain management?

Research suggests that combining ibuprofen and acetaminophen is generally safe and effective for pain relief, with common mild side effects like nausea and headache. Oxycodone combinations are also considered safe and effective, offering enhanced pain relief with a potentially improved side effect profile compared to using oxycodone alone. ^{1 6 7 8 9}

How does the ibuprofen and acetaminophen combo drug differ from other drugs for postoperative pain?

The ibuprofen and acetaminophen combo drug is unique because it combines two over-the-counter pain relievers into a single capsule, potentially offering more effective pain relief than either drug alone, without the stronger side effects associated with opioids like oxycodone. ^{2 4 10 11 12}

What is the purpose of this trial?

In the US, pain management after surgery for surgical treatment of osteoarthritis at the base of the thumb typically consists of prescription opioids during the early recovery phase. Given the highly addictive nature of prescription opioids, guidelines are being evaluated by hand surgeons to reduce opioid use while still maintaining pain control after surgery. A promising approach is to use non-narcotic medication as the first line of treatment. The purpose of this study is to demonstrate the efficacy of a combination of non-steroidal anti-inflammatory drugs (NSAIDs), ibuprofen and acetaminophen, in comparison to a morphine analogue substance (oxycodone) for pain management in the first 30 days after surgery.

Research Team

Amy Ladd, MD

Principal Investigator

Stanford Orthopaedic Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Ibuprofen vs. acetaminophen vs. ibuprofen and acetaminophen after arthroscopically assisted anterior cruciate ligament reconstruction. [2019]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Combining diclofenac with acetaminophen or acetaminophen-codeine after oral surgery: a randomized, double-blind single-dose study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. Sweden 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. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]

9. Spain pubmed.ncbi.nlm.nih.gov

Oxycodone combinations for pain relief. [2023]

10. United States 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. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Ibuprofen in the treatment of postoperative pain. [2020]