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Recruiting NCT03858231

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Phase IV Interventional Knee Injuries Pain, Postoperative Opioid Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Norco 5Mg-325Mg Tablet, Ibuprofen 600 mg, Acetaminophen 325Mg Tab.
Who it may be relevant to
Registry conditions: Knee Injuries, Pain, Postoperative, Opioid Use. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Norco 5Mg-325Mg Tablet
    1 tablet up to 4 times per day for 7 days
  • Drug Ibuprofen 600 mg
    1 tablet up to 4 times per day for 7 days
  • Drug Acetaminophen 325Mg Tab
    1 tablet up to 4 times per day for 7 days

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Sanford Health — Fargo

Identifiers

NCT: NCT03858231 · SH Opioid Knee

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗