Can Over-the-Counter painkillers replace opioids after knee surgery?
NCT ID NCT03858231
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares opioid (Norco) and non-opioid (ibuprofen and acetaminophen) pain medications in 148 adults undergoing knee arthroscopy. Participants take one tablet up to four times daily for seven days after surgery. The goal is to see if non-opioids provide similar pain relief and to understand how factors like gender and pre-surgery symptoms affect pain and medication use.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Norco (hydrocodone/acetaminophen), ibuprofen, and acetaminophen
- What this could lead to
- If successful, this could show that common non-opioid pain relievers are as effective as opioids for managing pain after knee arthroscopy, potentially reducing opioid use and addiction risks.
- What could go wrong
- This is a small, single-center Phase 4 trial, so results may not apply to all patients or surgeries. Pain is subjective, and individual responses may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 148 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2018
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects ≥ 18 years of age through ≤ 80 years of age 2. Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal. Exclusion Criteria: 1. Previously enrolled in this study (enrolled for contralateral knee in this study) 2. Knee arthroscopy patients scheduled for knee ligament reconstructions 3. Bilateral knee arthroscopy 4. History of chronic opioid use or long-term analgesic therapy 5. Documented or suspected substance abuse 6. Documented or suspected chronic pain syndrome 7. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen 8. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) 9. With active peptic ulcer disease (history of severe heartburn) 10. Symptoms of infection with initial enrollment 11. Pregnant or nursing 12. Diagnosis of cognitive impairment 13. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study 14. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by Institutional Review Board) and agree to abide by the study restrictions. 15. Patient refusal 16. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg. 17. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits. 18. Alcoholism
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sanford Health
RECRUITINGFargo, North Dakota, 58122, United States
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