Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
NCT ID: NCT03858231
Last Updated: 2024-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
148 participants
INTERVENTIONAL
2018-10-29
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Opioid
Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
Non-opioid
Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days
Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days
Interventions
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Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days
Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days
Eligibility Criteria
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Inclusion Criteria
2. Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.
Exclusion Criteria
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
18 Years
80 Years
ALL
No
Sponsors
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Sanford Health
OTHER
Responsible Party
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Principal Investigators
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Bruce Piatt, MD
Role: PRINCIPAL_INVESTIGATOR
Sanford Health
Locations
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Sanford Health
Fargo, North Dakota, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SH Opioid Knee
Identifier Type: -
Identifier Source: org_study_id
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