Development of a regional anesthesia guidance system to increase patient access to opioid-sparing analgesia for hip fracture pain

PROJECT SUMMARY/ABSTRACT For the >330,000 Americans that are hospitalized for hip fractures yearly, rapid treatment of pain and surgical intervention is critical to recover mobility and reduce the risk of death. Parenteral opioids are the standard of care to manage acute hip fracture pain but increase the risk of adverse events and outcomes, including delirium and recurrent opioid use. Ultrasound-guided regional anesthesia (UGRA) techniques, such as the pericapsular nerve group (PENG) block, are an effective alternative to opioids that could be used for > 300,000 patients annually to decrease consumption of opioids and improve outcomes. However, utilization of UGRA in the emergency department (ED) is primarily limited by ED-specific workflow challenges and lack of access to the training required for competency. Thus, there is a clear need to increase utilization of opioid-sparing UGRA for hip fracture pain, and it is likely that a technological advancement that reduces the training and workflow requirements of administering UGRA is required to meet this need. During this project, an ultrasound-based hip regional anesthesia guidance system will be developed under a quality management system (QMS) certified to ISO 13485:2016 and 21 CFR Part 820. The key technological innovations underpinning the development of this product include the following: 2D and 3D imaging algorithms that highlight bony anatomy and soft tissue landmarks, anatomical recognition capabilities that automate injection site selection, a novel dual-array ultrasound probe that enables ‘through-the-probe’ needle trajectories, a single-use sterile consumable designed to simplify workflow, and a needle-visualization imaging mode that highlights the advancing needle to the user. The primary technical tasks during the early stages of the project period include the execution of end-user clinical usability studies to guide technical specification development and implementation of machine learning networks to guide the PENG block. Successful completion of these technical aims will result in the fabrication of pre-production systems for pre- clinical validation studies that will be conducted later in the project period. Pre-clinical product validation activities will include cadaver and human-imaging studies performed in collaboration with clinical experts who will verify that the system meets the requirements for the clinical application. The primary endpoint for the pre-clinical cadaveric studies is a direct measurement of the accuracy of needle placement for the PENG block, as confirmed by CT imaging. Additionally, a second pre-clinical study using cadaveric specimens will characterize the learning curve required to reach competency with the system by studying the needle placement accuracy achieved by 25 ED physicians over multiple simulated procedures. Completion of this research project will result in the development and fabrication of a human clinical- trial-ready 3D-capable ultrasound-imaging system to support facile administration of UGRA for hip fracture pain by minimizing training and workflow barriers to utilization.