The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
概览
- 阶段
- 4 期
- 干预措施
- Norco 5Mg-325Mg Tablet
- 疾病 / 适应症
- Knee Injuries
- 发起方
- Sanford Health
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change from Baseline Pain Assessment at 2 weeks
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Opioid
干预措施: Norco 5Mg-325Mg Tablet
Non-opioid
干预措施: Ibuprofen 600 mg
Non-opioid
干预措施: Acetaminophen 325Mg Tab
结局指标
主要结局
Change from Baseline Pain Assessment at 2 weeks
时间窗: 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
时间窗: Daily for 14 days post-operatively
Patients will be asked how many study medication capsules have they taken.
次要结局
- Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks(baseline, 2 weeks, and 6 weeks post-operatively)
- Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks(baseline, 2 weeks, and 6 weeks post-operatively)