Outcomes After ACL Reconstruction: Femoral Nerve Block

ACL 重建后的结果：股神经阻滞

• 批准号: 6632759
• 负责人: BRIAN ALAN WILLIAMS
• 金额: $ 15.42万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-01 至 2006-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6632759
• 关键词: analgesia; anesthesia; autonomic block; clinical trials; experimental designs; human subject; human therapy evaluation; outcomes research; pain; patient oriented research; postoperative state

DESCRIPTION (Taken from the applicants abstract): This K-23 Research Career Award application is designed to provide an excellent training environment and project vehicle for the applicant to systematically design, implement, manage, and interpret randomized clinical trials. In the proposed project, the applicant aims to develop expertise in clinical trials to measure outcomes after anesthesia and pain management for common orthopedic procedures. The applicant will do this under supervision of the mentor, by attending graduate courses, and participating in tutorials with the mentor and consultants. The influence of nerve block pain management on outcomes after outpatient anterior cruciate ligament (ACL) reconstruction has not been studied, especially the potential to return to societal productivity during the first week after surgery. Therefore, the applicant will design and implement a randomized clinical trial to study the role of nerve block pain management techniques upon patient outcomes during the first week after surgery. The hypothesis is that patients undergoing nerve block analgesia will manifest better self-reported recovery outcomes, physical function outcomes, and objective measures of neuromuscular function. Consented patients (n=270) undergoing ACL reconstruction will receive conventional spinal anesthesia and be randomized to receive femoral nerve block analgesia with either a single-injection, a continuous infusion for 4 days, or saline placebo. Goniometry will be used to test postoperative range of motion in extension. to determine whether the quadriceps femoris torque output is impaired. Patient-reported recovery outcomes will be compared across treatment groups using three validated health status measures suitable for daily assessment (Verbal Pain Score, SF-8, and the Quality of Recovery [from anesthesia, QoR-40] Score). The first specific aim is to become proficient in clinical trials design, management, and interpretation through focused coursework and the project vehicle described. The second specific aim is to define a multi-dimensional outcomes model for outpatient orthopedic surgery and anesthesia, incorporating the dimensions of pain, physical function, and quality-of-life. The third specific aim is to determine the quality of immediate recovery (from anesthesia) and extent of reported pain, and to determine whether the use of nerve block analgesia is associated with impairment of quadriceps femoris torque output. Comparisons of single-injection and continuous infusion on femoral nerve analgesia will be performed to determine the better dosing strategy for these patients, relevant to the third specific aim. The program will train the applicant to perform as lead investigator of randomized clinical trials incorporating patientreported outcome measures. The methods learned and the model developed herein will be the basis of future studies funded through the R01 mechanism.

描述（取自申请人摘要）：这K-23研究生涯 奖项申请旨在提供一个良好的培训环境， 项目工具，供申请人系统地设计，实施，管理， 并解释随机临床试验。在拟议的项目中， 申请人旨在发展临床试验的专业知识，以衡量结果 在麻醉和疼痛管理后进行常规骨科手术。的 申请人将在导师的监督下完成这项工作， 课程，并与导师和顾问一起参加辅导。的 神经阻滞疼痛管理对门诊前路术后疗效的影响 交叉韧带（ACL）重建尚未研究，特别是 在第一周内恢复社会生产力的潜力 手术因此，申请人将设计并实施随机化 临床试验，研究神经阻滞疼痛管理技术在 术后第一周的患者结局。前提是 接受神经阻滞镇痛的患者将表现出更好的自我报告 恢复结果，身体功能结果，以及 神经肌肉功能接受ACL治疗的患者（n=270） 重建将接受传统的脊髓麻醉，并随机分配到 接受股神经阻滞镇痛，单次注射， 连续输注4天，或生理盐水安慰剂。测角法将用于 测试术后伸展运动范围。以确定是否 股四头肌扭矩输出受损。患者报告的恢复 将使用三种经过验证的健康状况对治疗组之间的结果进行比较。 适用于日常评估的状态测量（言语疼痛评分，SF-8和 恢复质量[麻醉后，QoR-40]评分）。第一个具体目标是 精通临床试验设计、管理和解释 通过集中的课程作业和所描述的项目工具。第二 具体目标是为门诊患者定义多维结果模型 整形外科手术和麻醉，包括疼痛的维度， 身体功能和生活质量。第三个具体目标是确定 立即恢复（从麻醉中）的质量和报告的程度 疼痛，并确定是否使用神经阻滞镇痛与 股四头肌扭矩输出受损。比较 单次注射和持续输注对股神经镇痛将 为这些患者确定更好的给药策略，相关 第三个具体目标。该计划将培训申请人履行作为 纳入患者报告的随机临床试验的首席研究员 结果测量。在此学习的方法和开发的模型将 通过R 01机制资助的未来研究的基础。