Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
Status: | Recruiting |
---|---|
Conditions: | Post-Surgical Pain, Orthopedic |
Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/2/2019 |
Start Date: | October 29, 2018 |
End Date: | January 2020 |
Contact: | Amy Tuchscherer |
Email: | amy.tuchscherer@sanfordhealth.org |
Phone: | (701) 417-6292 |
The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
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.
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.
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. Currently on daily use of ibuprofen, acetaminophen or other pain altering medication,
including medications like Neurontin (gabapentin) and Ultram (tramadol)
7. Documented or suspected chronic pain syndrome
8. Any known allergy or adverse reaction or contraindication to the components of
hydrocodone, acetaminophen, or ibuprofen
9. History or symptoms of any significant medical problem in the last year (i.e.,
arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver
disease, renal disease)
10. With active peptic ulcer disease (history of severe heartburn)
11. Symptoms of infection with initial enrollment
12. Pregnant or nursing
13. Diagnosis of cognitive impairment
14. Unable or unwilling to provide informed consent for surgery or enrollment in this
clinical study
15. 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.
16. Patient refusal
17. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that
increase bleeding
18. Patients with other medical or psychological health conditions that preclude them from
either receiving the intervention or returning for follow-up visits.
19. Alcoholism
We found this trial at
1
site
Fargo, North Dakota 58122
Principal Investigator: Bruce Piatt, MD
Phone: 701-417-6292
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