Developing and Testing an Opioid Taper Intervention Before Total Knee Arthroplasty

全膝关节置换术前开发和测试阿片类药物逐渐减量干预

• 批准号: 10525412
• 负责人: Kevin Riggs
• 金额: $ 16.97万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-05 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10525412
• 关键词: Adherence; Adopted; Analgesics; Award; Behavior; Caring; Characteristics; Chronic; Clinical; Clinical Pharmacists; Clinical Trials; Clinical Trials Design; Complication; Control Groups; Data; Degenerative polyarthritis; Dependence; Dose; Education; Educational Curriculum; Evaluation; Future; Goals; Health Services Research; Hyperalgesia; Instruction; Intervention; K-Series Research Career Programs; Knee; Knee Osteoarthritis; Lead; Literature; Measures; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methods; Operative Surgical Procedures; Opioid; Opioid Receptor; Outcome; Outcome Assessment; Outcome Measure; Pain; Pain management; Pain quality; Participant; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Perioperative; Persons; Pharmacists; Phase; Physicians; Pilot Projects; Positioning Attribute; Postoperative Pain; Postoperative Period; Preparation; Prospective Studies; Protocols documentation; Psychologist; Publishing; Quality of life; Randomized; Randomized Controlled Trials; Rehabilitation therapy; Replacement Arthroplasty; Research; Research Personnel; Retrospective Studies; Telephone; Testing; Training; Uncertainty; Visit; base; behavior change; career; chronic pain; clinical trial implementation; efficacy testing; efficacy trial; experience; functional restoration; functional status; implementation outcomes; improved; improved outcome; knee replacement arthroplasty; motivational enhancement therapy; multidisciplinary; non-cancer chronic pain; operation; opioid tapering; opioid use; pain reduction; pilot trial; post-operative rehabilitation; programs; randomized trial; recruit; retention rate; secondary outcome; skills; smoking cessation; surgery outcome; therapy development

PROJECT SUMMARY Osteoarthritis of the knee is one of the most common causes of chronic pain in the US, and a common reason that patients take long-term opioids for pain. Total knee arthroplasty is often used to treat advanced knee osteoarthritis, with nearly a million patients undergoing total knee arthroplasty in the US each year. Many patients who undergo total knee arthroplasty are taking opioids preoperatively. However, preoperative opioid use is associated with worse postoperative pain, higher complication rates, and higher postoperative opioid use. Even low dose opioids can induce dependence and hyperalgesia, so postoperative pain can be harder to control in patients who have been taking chronic opioids, which can then lead to more difficult rehabilitation after surgery. Tapering opioids preoperatively holds potential to improve outcomes in total knee arthroplasty by counteracting these negative effects of opioids. However, the existing literature on preoperative opioid taper is limited. Several small retrospective studies have suggested a benefit, but detailed preoperative taper protocols have not been published, and high quality prospective studies have not been conducted. This proposal looks to advance the field of preoperative opioid tapering. Aim 1 will develop and refine a preoperative opioid taper protocol for patients undergoing total knee arthroplasty. Aim 2 will assess the feasibility of preoperative opioid taper intervention in a pilot randomized trial. At the completion of the pilot trial in Aim 2, the intervention will be ready to be tested for efficacy in a multicenter randomized control trial as the next step in this research. The overall goal of this 4-year Mentored Patient-Oriented Research Career Development Award (K23) proposal is to support Kevin Riggs, MD, MPH to become an independent investigator in the field of improving arthroplasty outcomes, with a focus on pain and opioid use. This award will provide comprehensive mentoring, training, and research experience to facilitate Dr. Riggs’s progression toward becoming an independent investigator. Specifically, Dr. Riggs will gain expertise in developing interventions, clinical trial design, and evaluation of functional status and other patient-reported outcome measures. This will position Dr. Riggs to become a leader in improving surgical outcomes for patients undergoing arthroplasty.

项目摘要 膝关节骨关节炎是美国慢性疼痛最常见的原因之一，也是一个常见的原因。 病人长期服用阿片类药物来缓解疼痛全膝关节置换术常用于治疗晚期膝关节 骨关节炎，在美国每年有近一百万患者接受全膝关节置换术。许多 接受全膝关节置换术的患者在术前服用阿片类药物。然而，术前阿片类药物 使用与更严重的术后疼痛、更高的并发症发生率和更高的术后阿片类药物相关。 使用.即使是低剂量的阿片类药物也会引起依赖性和痛觉过敏，因此术后疼痛更难控制。 控制长期服用阿片类药物的患者，这可能导致更难康复 手术后。术前逐渐减少阿片类药物有可能改善全膝关节置换术的结局， 抵消阿片类药物的这些负面影响。然而，关于术前阿片类药物减量的现有文献 有限公司几项小型回顾性研究表明了一种益处，但详细的术前锥形方案 尚未发表，也未进行高质量的前瞻性研究。该提案旨在 推进术前阿片类药物减量领域。目标1将制定和完善术前阿片类药物减量 接受全膝关节置换术患者的方案。目的2将评估术前阿片类药物的可行性 在一项初步随机试验中逐渐减少干预。在目标2的试点试验完成后，干预措施将 准备在多中心随机对照试验中进行疗效测试，作为本研究的下一步。的 这项为期4年的指导性患者导向研究职业发展奖（K23）提案的总体目标是 支持Kevin Riggs，MD，MPH成为改善关节成形术领域的独立研究者 结果，重点是疼痛和阿片类药物的使用。该奖项将提供全面的指导，培训， 研究经验，以促进里格斯博士的进展，成为一名独立的调查员。 具体来说，里格斯博士将获得开发干预措施，临床试验设计和评估的专业知识。 功能状态和其他患者报告的结局指标。这将使里格斯博士成为领导者 改善关节成形术患者的手术效果。