121 Participants Needed

Ibuprofen & Acetaminophen vs Oxycodone for Postoperative Pain

Recruiting at 1 trial location
DK
AL
Overseen ByAmy Ladd, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.16789

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.24101112

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

AL

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)
See 5 more

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
2Treatment groups
Experimental Treatment
Group I: OpioidsExperimental Treatment1 Intervention
Following surgery will receive opioid capsules following surgery. Will take online and phone surveys.
Group II: NSAIDSExperimental Treatment1 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

Find a Clinic Near You

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

References

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]
Combination hydrocodone and ibuprofen versus combination oxycodone and acetaminophen in the treatment of postoperative obstetric or gynecologic pain. [2019]
Ibuprofen vs. acetaminophen vs. ibuprofen and acetaminophen after arthroscopically assisted anterior cruciate ligament reconstruction. [2019]
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]
Combining diclofenac with acetaminophen or acetaminophen-codeine after oral surgery: a randomized, double-blind single-dose study. [2020]
Acetaminophen, aspirin, or Ibuprofen in combination analgesic products. [2020]
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]
Comparative effect of paracetamol, NSAIDs or their combination in postoperative pain management: a qualitative review. [2022]
Oxycodone combinations for pain relief. [2023]
10.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Bromfenac sodium, acetaminophen/oxycodone, ibuprofen, and placebo for relief of postoperative pain. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Ibuprofen in the treatment of postoperative pain. [2020]
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