Fargo, North Dakota 58122

  • Opioid Use

Purpose:

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.


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. Currently on daily use of ibuprofen, acetaminophen or other pain altering medication, including medications like Neurontin (gabapentin) and Ultram (tramadol) 7. Documented or suspected chronic pain syndrome 8. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen 9. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) 10. With active peptic ulcer disease (history of severe heartburn) 11. Symptoms of infection with initial enrollment 12. Pregnant or nursing 13. Diagnosis of cognitive impairment 14. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study 15. 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. 16. Patient refusal 17. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding 18. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits. 19. Alcoholism


NCT ID:

NCT03858231


Primary Contact:

Principal Investigator
Bruce Piatt, MD
Sanford Health

Amy Tuchscherer
Phone: (701) 417-6292
Email: amy.tuchscherer@sanfordhealth.org


Backup Contact:

Email: Katie.E.Jensen@SanfordHealth.org
Katie Jensen
Phone: (605) 312-6983


Location Contact:

Fargo, North Dakota 58122
United States

Amy Tuchscherer
Phone: 701-417-6292
Email: amy.tuchscherer@sanfordhealth.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 05, 2021

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