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RecruitingPhase 4NCT03858231

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study

Sponsor

Sanford Health

Enrollment

148 participants

Start Date

Oct 29, 2018

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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 Criteria18

  • 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.
  • Alcoholism

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Interventions

DRUGNorco 5Mg-325Mg Tablet

1 tablet up to 4 times per day for 7 days

DRUGIbuprofen 600 mg

1 tablet up to 4 times per day for 7 days

DRUGAcetaminophen 325Mg Tab

1 tablet up to 4 times per day for 7 days

Locations(1)

Sanford Health

Fargo, North Dakota, United States

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NCT03858231