Intercostal Nerve Cryoablation Versus Thoracic Epidural Analgesia for Minimally Invasive Repair of Pectus Excavatum: A Randomized Clinical Trial (ICE-Trial)

OBJECTIVES: Postoperative pain after the Nuss procedure remains a significant burden for patients. While thoracic epidural analgesia (TEA) has been the standard for postoperative pain management, intercostal nerve cryoablation (INC) has emerged as a promising alternative. Hence, we aimed to determine the impact of INC on recovery after the Nuss procedure for pectus excavatum in comparison to TEA. METHODS: This single-centre, unblinded, randomized clinical trial (NCT05731973) was conducted at Zuyderland Medical Center, The Netherlands. Participants aged 12 to 24 years and scheduled for the Nuss procedure were randomly allocated to receive either INC or TEA. The study used a superiority design for the primary outcome, length of hospital stay (LOHS). RESULTS: Fifty patients were randomized, of which 48 were included in the intention-to-treat analysis (INC n = 25, TEA n = 23). A significant reduction in LOHS was seen (INC 1 day [interquartile range (IQR) 1-1] vs TEA 4 days [IQR 4-4]; P < .001, r = -0.94). Further reductions were seen in opioid consumption (83% during hospitalization and 97% after discharge, P < .001) and postoperative pain on day 7 (P = .010) and 14 (P = .035). Patients showed increased mobilization on day 1 (P = .012) and 2 (P = .013); however, no significant differences were seen in return to work/school. Persistent chest wall hypoesthesia at 6 months postoperatively was seen in 56% of patients after INC. CONCLUSIONS: INC demonstrates superiority over TEA in reducing LOHS, opioid use and pain postoperatively. However, persistent chest wall hypoesthesia at 6 months postoperatively remains an issue that warrants further investigation into the long-term effects of INC. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT05731973. URL: https://clinicaltrials.gov/study/NCT05731973.