Italian Registry of Complications associated with Regional Anesthesia (RICALOR). An incidence analysis from a prospective clinical survey

BACKGROUND: Regional anesthesia (RA) is associated with many advantages, but side effects also occur. Several registries were developed to investigate such complications in many countries, which produced conflicting results. In consideration of the ongoing evolution and improvements in RA, and its widespread diffusion in Italy in the last decade (with increasing experience by anesthesiologists), a reappraisal of the incidence and the characteristics of major complications are useful to improve patient's safety. METHODS: A web-based prospective registry was developed in Italy with: 1) quarterly report of total anesthetic acts and RA procedures performed; and 2) voluntary registration of complications on dedicated forms. We evaluated incidence of complications, describing their characteristics and outcomes. RESULTS: Participants (N.=17 hospitals) registered 117,182 procedures, including 63,692 with RA (54.3%, both as primary anesthetic technique and for postoperative analgesia). A total of 34,147 neuraxial blocks (4954 epidurals/CSE, 29,193 subarachnoid blocks) and 29,545 peripheral (single shot and continuous) blocks were registered. Total incidence of complication was 4.6/10.000; incidence was 4.1/10,000 for central blocks and 5.1/10,000 for peripheral blocks, long-term neurologic deficit (at 6 months) was observed after an epidural abscess, while other complications did not lead to any long-term adverse outcomes. No hemorrhagic events or other infections have occurred. Incidence of major complications was 0.07/1000, while minor complications presented in 0.38/1000 cases. CONCLUSIONS: We confirmed RA as generally safe, but monitoring and diagnosis, together with further research efforts, are needed to improve patients' care and clarify potential risk factors..