NCT03858231 · Sanford Health
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
What this study is about
The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy.
View original scientific description
The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. This study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.
Interventions
DRUG
Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
DRUG
Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days
DRUG
Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days
Primary outcome measures
Change from Baseline Pain Assessment at 2 weeks
Time frame: Daily for 2 weeks post-operatively
Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain
Change from Baseline Medication Use at 2 weeks
Time frame: Daily for 14 days post-operatively
Patients will be asked how many study medication capsules have they taken.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects ≥ 18 years of age through ≤ 80 years of age
- Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.
Exclusion criteria
- Previously enrolled in this study (enrolled for contralateral knee in this study)
- Knee arthroscopy patients scheduled for knee ligament reconstructions
- Bilateral knee arthroscopy
- History of chronic opioid use or long-term analgesic therapy
- Documented or suspected substance abuse
- Documented or suspected chronic pain syndrome
- Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen
- History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
- With active peptic ulcer disease (history of severe heartburn)
- Symptoms of infection with initial enrollment
- Pregnant or nursing
- Diagnosis of cognitive impairment
- Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study
- 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.
- Patient refusal
- Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg.
- Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.
Where
- Fargo, North Dakota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations