NCT03858231 Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
| NCT ID | NCT03858231 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Sanford Health |
| Condition | Knee Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 148 participants |
| Start Date | 2018-10-29 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 148 participants in total. It began in 2018-10-29 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Bruce Piatt, MD
PRINCIPAL INVESTIGATOR
Sanford Health
Frequently Asked Questions
Who can join the NCT03858231 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Knee Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03858231 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03858231 currently recruiting?
Yes, NCT03858231 is actively recruiting participants. Contact the research team at amy.tuchscherer@sanfordhealth.org for enrollment information.
Where is the NCT03858231 trial being conducted?
This trial is being conducted at Fargo, United States.
Who is sponsoring the NCT03858231 clinical trial?
NCT03858231 is sponsored by Sanford Health. The principal investigator is Bruce Piatt, MD at Sanford Health. The trial plans to enroll 148 participants.