Outcomes After ACL Reconstruction: Femoral Nerve Block

描述(摘自申请者摘要)：这份K-23研究生涯 奖项申请旨在提供良好的培训环境和 为申请者系统地设计、实施、管理、 并解读随机临床试验。在拟议的项目中， 申请者的目标是发展临床试验方面的专业知识，以衡量结果 用于常见骨科手术的麻醉和疼痛处理后。这个 申请者将在导师的监督下，通过参加研究生课程来完成这项工作 课程，并与导师和顾问一起参加教程。这个 神经阻滞疼痛管理对门诊前路手术后预后的影响 十字韧带(ACL)重建尚未见文献报道，尤其是 在之后的第一周内恢复社会生产力的潜力 做手术。因此，申请者将设计并实施一种随机的 临床试验研究神经阻滞疼痛管理技术在 术后第一周的患者预后。假设是这样的 接受神经阻滞镇痛的患者将表现出更好的自我报告 康复结果、身体功能结果和客观测量 神经肌肉功能。270例接受前交叉韧带手术的患者 重建术将接受常规脊麻，并被随机分配到 接受股神经阻滞止痛，一次注射，一次 连续输液4天，或生理盐水安慰剂。测角技术将用于 测试术后伸展活动范围。以确定是否 股四头肌扭矩输出受损。患者报告的康复情况 将使用三种经过验证的健康来比较不同治疗组的结果 适合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 精通临床试验的设计、管理和解释 通过有重点的课程作业和项目车辆描述。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，结合了疼痛的维度， 身体机能和生活质量。第三个具体目标是确定 立即恢复的质量(从麻醉中)和报告的程度 疼痛，并确定使用神经阻滞止痛是否与 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的镇痛作用 为这些患者确定更好的给药策略，相关 达到第三个具体目标。该计划将培训申请者执行以下操作 纳入患者报告的随机临床试验的首席研究员 结果衡量标准。在此学习的方法和开发的模型将是 通过R01机制资助的未来研究的基础。

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.