Clinical trial NCT03858231: Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery
Official title: The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Knee Injuries
Pain, Postoperative
Opioid Use
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change from Baseline Pain Assessment at 2 weeks
timeFrame: Daily for 2 weeks post-operatively
measure: Change from Baseline Medication Use at 2 weeks
timeFrame: Daily for 14 days post-operatively
Secondary outcomes:
measure: Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
timeFrame: baseline, 2 weeks, and 6 weeks post-operatively
measure: Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks
timeFrame: baseline, 2 weeks, and 6 weeks post-operatively
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Sanford Health
state: North Dakota
Study officials:
affiliation: Sanford Health
name: Bruce Piatt, MD
role: PRINCIPAL_INVESTIGATOR
References: