Ultrasound-Guided Percutaneous Cryoneurolysis for the Treatment of Pain following Traumatic Rib Fracture: A Randomized, Active-Controlled, Participant- and Observer-Masked Study

Background. Traumatic rib fractures are associated with pain lasting weeks to months and a decreased ability to inspire deeply or cough to clear secretions. Ultrasound-guided percutaneous cryoneurolysis involves reversibly ablating peripheral nerve(s) using exceptionally low temperature with a transdermal probe, resulting in a prolonged nerve block with a duration measured in months. We hypothesized that cryoneurolysis would improve analgesia and inspired volume following rib fracture. Methods. Adults with 1-6 traumatic rib fractures were randomized to either active cryoneurolysis and a sham peripheral nerve block (PNB), or sham cryoneurolysis and active PNB in a participant/observer-masked fashion. The primary endpoint was the maximum inspired volume the day after the procedure as measured with an incentive spirometer. Results. The day after the procedure, the unadjusted median [IQR] maximum inspired volume for participants who received cryoneurolysis (n=11) was 2,250 mL [1,500; 2,500] versus 1,300 mL [750; 2,500] for PNB (n=9, mean difference 496; 95%CI -428 to 1420; t-test P=0.269). When adjusted for covariates (e.g., baseline lung volume), the cryoneurolysis group had an estimated 793 mL greater mean volume than PNB (95%CI 273 to 1,312; ANCOVA P=0.005). Improvement from baseline in maximum inspired volume for cryoneurolysis was 1,000 mL [1,000; 1,375] versus 300 mL [0; 1,000] for PNB (t-test P=0.002). This was equivalent to an improvement over baseline of 100% [90%, 188%] for cryoneurolysis versus 30% [0%, 50%] for PNB (t-test P=0.003). Average daily pain scores were generally lower for the cryoneurolysis group throughout the first month. Total cumulative oxycodone equivalents were 5 mg [0, 13] for cryoneurolysis vs 45 mg [43, 135] for PNB (t-test P=0.013). Conclusions. Ultrasound-guided percutaneous cryoneurolysis improves maximum inspired lung volume while concurrently decreasing pain and opioid consumption after traumatic rib fracture. These results should be considered preliminary, requiring confirmation with a trial including a larger sample size.