Benjamin Padilla and Michael Harrison Awarded NIH R03 for Cryoanalgesia Study

The Eunice Kennedy Shriver National Institute of Children Health & Human Development (NICHD) at the National Institutes of Health (NIH) has awarded pediatric surgeons Benjamin Padilla, MD, and Michael Harrison, MD, a two-year grant to study the use of cryoanalgesia as a novel method of pain control in the Nuss Procedure. The research team includes Sunghoon Kim, MD, and Jill Imamura-Ching, RN. Claire Graves, MD, played a key role in setting up the project and developing the grant application while she was a resident in the Innovation Pathway from 2015 to 2017.

The Nuss Procedure is a minimally invasive repair for individuals with pectus excavatum, or sunken chest disorder. During the surgery, which is most commonly done during adolescence, a steel bar is placed under the sternum and ribs and then flipped, causing the chest to pop out into a normal position.  Although effective, patients experience severe post-operative pain, which current pain management methods (thoracic epidural and patient-controlled analgesia) cannot adequately control and which can lead to dependence on opioids and long-term pain issues.

This study is a prospective, randomized trial comparing cryoanalgesia to thoracic epidural analgesia in post-operative pain control on adolescent and young adult patients who have undergone the Nuss Procedure. Cryoanalgesia is a novel technology that locally freezes the peripheral nerves, causing nerve axons to degenerate. The result is temporary prevention of pain transmission, with complete axonal regeneration occurring in approximately 4-6 weeks. If effective, this pain control strategy could shorten hospital stays and decrease pain and opiate usage among Nuss procedure patients.

This will not be the first time Drs. Harrison and Padilla have collaborated on a study to advance the state of the art in pectus excavatum treatment. For years, they have worked together on the Magnetic Mini-Mover Project, a novel device that uses magnetic force to gradually reform the chest wall over a two-year period. The procedure was devised as an alternative to the painful Nuss Procedure and has been evaluated in two clinical trials under an Investigative Device Exemption (IDE) from the FDA. Currently, the team is working to optimize the device design in preparation for a third human trial.