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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23AR047631-05
Application #
6853548
Study Section
Special Emphasis Panel (ZAR1-TAS-A (J1))
Program Officer
Panagis, James S
Project Start
2001-04-01
Project End
2007-02-28
Budget Start
2005-03-01
Budget End
2007-02-28
Support Year
5
Fiscal Year
2005
Total Cost
$156,043
Indirect Cost
Name
University of Pittsburgh
Department
Anesthesiology
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Williams, Brian A; Dang, Qainyu; Bost, James E et al. (2009) General health and knee function outcomes from 7 days to 12 weeks after spinal anesthesia and multimodal analgesia for anterior cruciate ligament reconstruction. Anesth Analg 108:1296-302
Williams, Brian A; Bottegal, Matthew T; Kentor, Michael L et al. (2007) Rebound pain scores as a function of femoral nerve block duration after anterior cruciate ligament reconstruction: retrospective analysis of a prospective, randomized clinical trial. Reg Anesth Pain Med 32:186-92
Williams, Brian A; Kentor, Michael L; Irrgang, James J et al. (2007) Nausea, vomiting, sleep, and restfulness upon discharge home after outpatient anterior cruciate ligament reconstruction with regional anesthesia and multimodal analgesia/antiemesis. Reg Anesth Pain Med 32:193-202
Bost, James E; Williams, Brian A; Bottegal, Matthew T et al. (2007) The 8-item Short-Form Health Survey and the physical comfort composite score of the quality of recovery 40-item scale provide the most responsive assessments of pain, physical function, and mental function during the first 4 days after ambulatory knee sur Anesth Analg 105:1693-700, table of contents
Williams, Brian A; Bottegal, Matthew T; Francis, Kimberly A et al. (2007) A post hoc analysis of research study staffing: budgetary effects of the Health Insurance Portability and Accountability Act on research staff work hours during a prospective, randomized clinical trial. Anesthesiology 107:860-1
Williams, Brian A (2006) Potential economic benefits of regional anesthesia for acute pain management: the need to study both inputs and outcomes. Reg Anesth Pain Med 31:95-9
Williams, Brian A; Kentor, Michael L; Vogt, Molly T et al. (2006) Reduction of verbal pain scores after anterior cruciate ligament reconstruction with 2-day continuous femoral nerve block: a randomized clinical trial. Anesthesiology 104:315-27
Williams, Brian A; Beaman, Shawn T; Kentor, Michael L (2005) Regional anesthesia group practice in the university hospital setting and ambulatory/regional anesthesia clinical pathway formulation. Int Anesthesiol Clin 43:3-13
Williams, Brian A; Motolenich, Peter; Kentor, Michael L (2005) Hospital facilities and resource management: economic impact of a high-volume regional anesthesia program for outpatients. Int Anesthesiol Clin 43:43-51
Kentor, Michael L; Williams, Brian A (2005) Antiemetics in outpatient regional anesthesia for invasive orthopedic surgery. Int Anesthesiol Clin 43:205-13

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