NCT02626533已完成不适用
Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2015年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)
研究概览
简要总结
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective primary unilateral total knee arthroplasty
- •Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
- •Patients of surgeons who have agreed to participate in the study
- •Age > 18 years
- •American Society of Anesthesiologists (ASA) Physical Status 1-3
- •Regional anesthesia
- •Epidural patient-controlled analgesia (PCA) for postoperative pain
- •Adductor canal block for postoperative pain
排除标准
- •Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
- •Use of general anesthesia
- •History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
- •Preoperative oral steroid use in the past 6 months
- •Intra-articular steroid injection within one month of scheduled surgery in affected joint
- •Non-English speakers
- •Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
- •Peri-articular injections or infusions for postoperative pain
- •Diagnosis of crystalline arthropathy
- •Diagnosis of osteonecrosis
- •Active infection or use of antibiotics
- •Pregnant women
结局指标
主要结局
Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)
时间窗: 6 months after date of surgery
Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint. A lower score is a better outcome. 0 is no pain, and 10 is worst pain imaginable.
次要结局
- Patients Who Experienced Postoperative Joint Stiffness(6 weeks after date of surgery)
- NRS Pain at Rest on POD1(1 day after surgery)
- NRS Pain With Movement on POD1(1 day after surgery)
- NRS Pain at Rest 4 Weeks After Surgery(4 weeks after surgery)
- NRS Pain at Rest 3 Months After Surgery(3 months after surgery)
- Worst NRS Pain 3 Months After Surgery(3 months after date of surgery)
- Postoperative Knee Range of Motion(6 weeks after date of surgery)
- Worst NRS Pain on POD1(1 day after surgery)
- Least NRS Pain on POD2(2 days after surgery)
- NRS Pain With Movement 3 Months After Surgery(3 months after surgery)
- NRS Pain With Movement on POD2(2 days after surgery)
- NRS Pain at Rest 6 Months After Surgery(6 months after date of surgery)
- Worst NRS Pain on POD2(2 days after surgery)
- Worst NRS Pain 4 Weeks After Surgery(4 weeks after surgery)
- Least NRS Pain 3 Months After Surgery(3 months after date of surgery)
- Least NRS Pain on POD1(1 day after surgery)
- NRS Pain at Rest on POD2(2 days after surgery)
- NRS Pain With Movement 4 Weeks After Surgery(4 weeks after surgery)
- Least NRS Pain 4 Weeks After Surgery(4 weeks after surgery)
- Least NRS Pain 6 Months After Surgery(6 months after date of surgery)
- Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores(4 weeks, 3 months, and 6 months after date of surgery)
- Postoperative painDETECT Scores(4 weeks, 3 months, and 6 months after date of surgery)
- Types of Preoperative Medications(Before surgery)
- Worst NRS Pain 6 Months After Surgery(6 months after date of surgery)
研究者
研究点 (1)
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