The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change from Baseline Pain Assessment at 2 weeks
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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.
研究组 & 干预措施
Opioid
干预措施: Norco 5Mg-325Mg Tablet (Drug)
Non-opioid
干预措施: Ibuprofen 600 mg (Drug)
Non-opioid
干预措施: Acetaminophen 325Mg Tab (Drug)
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)