Ultrasound-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture, a Pilot Randomized Control Trial (UNPIN Trial)

What this Trial Is About

Traumatic rib fractures, which result from physical injury, are common and cause significant pain. These fractures can lead to serious complications, longer hospital stays, and even death. Pain from rib fractures may persist long after healing, affecting quality of life. This research evaluates cryoneurolysis, a technique that freezes nerves causing pain, as a new method to manage rib fracture pain alongside standard pain control. The study is a pilot randomized trial assessing the feasibility of using this technology for such patients. Participants aged 18 to 85 with 3 to 8 unilateral traumatic rib fractures will be randomly assigned to one of two groups. One group will receive standard pain care including multimodal analgesia and an erector spinae plane (ESP) catheter infusion, plus the cryoneurolysis procedure using a handheld device guided by ultrasound. The other group will receive the same standard care plus a sham cryoneurolysis procedure to maintain blinding. Both groups will receive injections and infusions of local anesthetics and other pain medications as needed. During the three-month study period, participants will be monitored daily in the hospital and will keep a pain diary after discharge, recording weekly pain scores and daily opioid usage. Follow-up visits will occur at 1 hour, 24 hours, 48 hours, 1 week, 1 month, and 3 months after the procedure. Researchers will measure recruitment success, protocol adherence, pain severity, opioid consumption, pulmonary function, patient satisfaction, adverse events, and the incidence of chronic pain. The study aims to gather data to support a larger trial on cryoneurolysis effectiveness.

UltrasouNd-guided Percutaneous Intercostal Nerve Cryoneurolysis for Analgesia Following Traumatic Rib Fracture