Recruiting

Opioids vs. Non-Opioids

Sponsor:

Sanford Health

Code:

NCT03858231

Conditions

Knee Injuries

Pain, Postoperative

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Norco 5Mg-325Mg Tablet

Ibuprofen 600 mg

Acetaminophen 325Mg Tab

Study Details

Brief 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 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

Study ID

NCT03858231

Start date

Oct 29, 2018

Status verified date

Feb, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

148 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Opioid

active comparator: Non-opioid

Interventions

Norco 5Mg-325Mg Tablet

1 tablet up to 4 times per day for 7 days

Ibuprofen 600 mg

1 tablet up to 4 times per day for 7 days

Acetaminophen 325Mg Tab

1 tablet up to 4 times per day for 7 days

Primary outcome measure

  • Change from Baseline Pain Assessment at 2 weeks [ Time Frame: Daily for 2 weeks post-operatively ]
  • Change from Baseline Medication Use at 2 weeks [ Time Frame: Daily for 14 days post-operatively ]

Central Contacts and Locations

Locations

Sanford Health

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Bruce Piatt, MD

More Information

Sponsor

Sanford Health

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanford Health on 2026-02-10.