Clinical trial

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

Name
SH Opioid Knee
Description
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.
Trial arms
Trial start
2018-10-29
Estimated PCD
2025-12-01
Trial end
2026-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
Arms:
Opioid
Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days
Arms:
Non-opioid
Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days
Arms:
Non-opioid
Size
148
Primary endpoint
Change from Baseline Pain Assessment at 2 weeks
Daily for 2 weeks post-operatively
Change from Baseline Medication Use at 2 weeks
Daily for 14 days post-operatively
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 148, 'type': 'ESTIMATED'}}
Updated at
2024-02-26

1 organization

3 products

4 indications

Organization
Sanford Health
Product
Norco
Indication
Knee Injuries
Indication
Pain
Indication
Postoperative
Indication
Opioid Use
Product
Ibuprofen