Status:
RECRUITING
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
Lead Sponsor:
Sanford Health
Conditions:
Knee Injuries
Pain, Postoperative
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03858231
Start Date
October 29 2018
End Date
January 1 2026
Last Update
February 26 2024
Active Locations (1)
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1
Sanford Health
Fargo, North Dakota, United States, 58122