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.
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