Abstract
BACKGROUND: Patients undergoing Pectus Excavatum repair with the minimally invasive approach frequently report severe postoperative pain. The goal of the study is to determine the superiority of cryoanalgesia compared to standard of care for return to normal quality of life. METHODS: A randomized, active controlled, parallel groups trial (category IIb medical device) was designed for patients undergoing pectus excavatum repair. Participants were screened from the elective surgical lists at Istituto Gaslini, Genova, Italy, and they all were part of the academic practice setting. Once enrolled, patients were randomly assigned to one of the two study arms: cryoanalgesia vs. standard of care (epidural-based analgesia). The primary outcome was the Pediatric Quality of Life (PedsQL) and the subcomponents (psychosocial and physical health) 14 days after surgery. RESULTS: Protocol was approved by the Ethics Committee (278/2021-DB id 11 421) and conducted between February 2022 and October 2023. Eighty-eight patients were enrolled in the study: forty-five to cryoanalgesia and forty-three in the epidural arm. The PedsQL median (IQR) at the 14th day was 59.8 (48.4, 71.2) vs. 67.9 (58.7, 73.9) (95% CI: 0.46-13; difference 6.5; p = 0.07) with ITT analysis, and 59.8 (48.37, 71.20) vs. 69.02 (58.70, 73.91) (95% CI: 0.82, 14; difference 7.4; p = 0.028) with PP analysis, in the cryoanalgesia and in the standard of care group, respectively. Irrespective of treatment, a significant decrease in both the PedsQL total score and its subcomponents was found. This effect persisted when stratified by treatment: physical health showed a decrease in both arms, while psychosocial health demonstrated a more marked decrease in the standard of care arm (q-value = 0.028), but not in the cryoanalgesia arm (q-value = 0.056). CONCLUSIONS: Cryoanalgesia did not improve return to baseline quality of life 2 weeks after surgery. However, it showed to be beneficial in the psychosocial component of the PedsQL scale. TRIAL REGISTRATION: NCT05201820.