Knee InjuriesPhase 4NCT03858231
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
A Phase 4 study testing Norco 5Mg-325Mg Tablet, Ibuprofen 600 mg and Acetaminophen 325Mg Tab in people with Knee Injuries and Pain, Postoperative, run by Sanford Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Injuries, Pain, Postoperative, Opioid Use
- What is being tested?
- Norco 5Mg-325Mg Tablet, Ibuprofen 600 mg and Acetaminophen 325Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
- Alcoholism
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sanford Health
Fargo, North Dakota, 58122
Kathy Mcevoy, (701) 417-6928, kathryn.mcevoy@sanfordhealth.org
Katie Jensen, (605) 312-6983, Katie.E.Jensen@SanfordHealth.org
About this study
Official title: The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
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.
- Conditions
- Knee Injuries, Pain, Postoperative, Opioid Use
- Being tested
- Norco 5Mg-325Mg Tablet, Ibuprofen 600 mg, Acetaminophen 325Mg Tab
- Medical subject headings
- Knee Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norco 5Mg-325Mg TabletDrug
1 tablet up to 4 times per day for 7 days
Ibuprofen 600 mgDrug
1 tablet up to 4 times per day for 7 days
Acetaminophen 325Mg TabDrug
1 tablet up to 4 times per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Opioid | Active comparator | Not described Receives: Drug: Norco 5Mg-325Mg Tablet |
| Non-opioid | Active comparator | Not described Receives: Drug: Ibuprofen 600 mg; Drug: Acetaminophen 325Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Pain Assessment at 2 weeks
Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain
Measured: Daily for 2 weeks post-operatively
Change from Baseline Medication Use at 2 weeks
Patients will be asked how many study medication capsules have they taken.
Measured: Daily for 14 days post-operatively
Secondary outcomes (2)
Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Sub-scales are listed as follows: 5 qualitative questions related to knee symptoms ranging from "never" to "always", 2 qualitative questions related to knee stiffness ranging from "none" to "extreme", 9 qualitative questions related to pain ranging from "none" to "extreme", 17 qualitative questions related to function and daily living ranging from "none" to "extreme", 5 qualitative questions related to function and sports and recreational activities ranging from "none" to "extreme", and 4 qualitative questions related to quality of life ranging from "never or not at all" to "constantly, totally, or extreme".
Measured: baseline, 2 weeks, and 6 weeks post-operatively
Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks
7 qualitative questions related to pain interference with responses ranging from "not at all" to "very much"
Measured: baseline, 2 weeks, and 6 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start29 Oct 2018
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce Piatt, MD, Principal investigator, Sanford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858231
- Sponsor's protocol ID
- SH Opioid Knee
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03858231
- Acronym / sponsor ID
- SH Opioid Knee
- Conditions
- Knee Injuries, Pain, Postoperative, Opioid Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid | Active comparator | Drug: Norco 5Mg-325Mg Tablet |
| Non-opioid | Active comparator | Drug: Ibuprofen 600 mg, Drug: Acetaminophen 325Mg Tab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norco 5Mg-325Mg Tablet1 tablet up to 4 times per day for 7 days | Drug | Opioid |
| Ibuprofen 600 mg1 tablet up to 4 times per day for 7 days | Drug | Non-opioid |
| Acetaminophen 325Mg Tab1 tablet up to 4 times per day for 7 days | Drug | Non-opioid |
Primary outcome
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.
2 secondary outcomes
Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Time frame: baseline, 2 weeks, and 6 weeks post-operatively
Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks
Time frame: baseline, 2 weeks, and 6 weeks post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Piatt, MD principal investigator
Sanford Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norco 5Mg-325Mg Tablet, Ibuprofen 600 mg and Acetaminophen 325Mg Tab in people with Knee Injuries and Pain, Postoperative, run by Sanford Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Tuchscherer ((701) 417-6292, amy.tuchscherer@sanfordhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Pain Assessment at 2 weeks (time frame: Daily for 2 weeks post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.