Knee Injuries, Pain, Postoperative, Opioid Use
Conditions
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 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.
Interventions
1 tablet up to 4 times per day for 7 days
DRUGIbuprofen 600 mg
1 tablet up to 4 times per day for 7 days
DRUGAcetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days
Sponsors
Sanford Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Pain Assessment at 2 weeks | Daily for 2 weeks post-operatively | Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain |
| Change from Baseline Medication Use at 2 weeks | Daily for 14 days post-operatively | Patients will be asked how many study medication capsules have they taken. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks | baseline, 2 weeks, and 6 weeks post-operatively | 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". |
| Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks | baseline, 2 weeks, and 6 weeks post-operatively | 7 qualitative questions related to pain interference with responses ranging from "not at all" to "very much" |
Countries
United States
Contacts
CONTACTAmy Tuchscherer
CONTACTKatie Jensen
PRINCIPAL_INVESTIGATORBruce Piatt, MD
Sanford Health
Outcome results
None listed