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

> **NIH NIH R44** · RIVANNA MEDICAL, INC. · 2024 · $1,005,539

## Abstract

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 ultraso...

## Key facts

- **NIH application ID:** 10927446
- **Project number:** 5R44AR083337-02
- **Recipient organization:** RIVANNA MEDICAL, INC.
- **Principal Investigator:** Frank William Mauldin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,005,539
- **Award type:** 5
- **Project period:** 2023-09-11 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10927446

## Citation

> US National Institutes of Health, RePORTER application 10927446, Development of a regional anesthesia guidance system to increase patient access to opioid-sparing analgesia for hip fracture pain (5R44AR083337-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10927446. Licensed CC0.

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