Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Sanford Health

Status and phase: Enrolling; Phase 4

Conditions: Knee Injuries; Pain, Postoperative; Opioid Use

Treatments: Drug: Acetaminophen 325Mg Tab; Drug: Ibuprofen 600 mg; Drug: Norco 5Mg-325Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03858231

SH Opioid Knee

Details and patient eligibility

About

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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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148 participants in 2 patient groups

Opioid

Active Comparator group

Treatment:

Drug: Norco 5Mg-325Mg Tablet

Non-opioid

Active Comparator group

Treatment:

Drug: Acetaminophen 325Mg Tab

Drug: Ibuprofen 600 mg