Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Knee Injuries, Pain, Postoperative, Opioid Use

Intervention / Treatment
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* Drug: Norco 5Mg-325Mg Tablet
* Drug: Ibuprofen 600 mg
* Drug: Acetaminophen 325Mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioid<br> | Drug: Norco 5Mg-325Mg Tablet<br>* 1 tablet up to 4 times per day for 7 days<br>|
| Active Comparator: Non-opioid<br> | Drug: Ibuprofen 600 mg<br>* 1 tablet up to 4 times per day for 7 days<br>Drug: Acetaminophen 325Mg Tab<br>* 1 tablet up to 4 times per day for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Pain Assessment at 2 weeks | Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain | Daily for 2 weeks post-operatively | 
| Change from Baseline Medication Use at 2 weeks | Patients will be asked how many study medication capsules have they taken. | Daily for 14 days post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks | Sub-scales are listed as follows: 5 qualitative questions related to knee symptoms ranging from never to always, 2 qualitative questions related to knee stiffness ranging from none to extreme, 9 qualitative questions related to pain ranging from none to extreme, 17 qualitative questions related to function and daily living ranging from none to extreme, 5 qualitative questions related to function and sports and recreational activities ranging from none to extreme, and 4 qualitative questions related to quality of life ranging from never or not at all to constantly, totally, or extreme. | baseline, 2 weeks, and 6 weeks post-operatively | 
| Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks | 7 qualitative questions related to pain interference with responses ranging from not at all to very much | baseline, 2 weeks, and 6 weeks post-operatively |