Study population
infection, allergy, ESPB
INFECTION, ALLERGY, COAGULOPATHY
The current study was approved by the local ethical committee of Romagna (CEROM), registration number 1220 version 1.0, on 08/10/2020, and registered on ClinicalTrials.gov (NCT04729049) on 28/01/2021. It also adheres to the principles outlined in the Declaration of Helsinki. The enrolment phase was between February 2021 and June 2022. Our centre is a hub for neurosurgery and neuro-intensive care for a population of approximately 1,000,000, provided from a 32-bed neurosurgery unit, two neurosurgical theatres 5 days-per-week for elective surgeries (plus emergency activity), and approximately 500 spine surgeries per year.The inclusion criteria were: (1) adult patients (between 18 and 85-year old) undergoing elective or urgent (within days from diagnosis) spinal fusions; (2) spinal fusions involving up to 4 consecutive vertebral spaces at thoracic or lumbar levels; (3) patients classified according to the American Society of Anesthesiology (ASA) as I, II, and III.The exclusion criteria were: (1) allergy to local anaesthetics; (2) infection at the puncture site; (3) coagulopathy; (4) denial of consent from the patient; (5) need for emergent surgery (within hours from diagnosis); (6) patients classified as ASA IV or above; (7) chronic use of opioids; (8) patients who underwent previous spine surgery; (9) body mass index above 40.Randomization was ensured by an informatically generated random sequence run by a clinician not involved in the study. Patients were informed during the preoperative anesthesiology evaluation, then they signed the informed consent forms at the preoperative re-evaluation the evening before surgery: 30 patients fulfilled the inclusion criteria during the study period and were enrolled, providing 15 cases and 15 controls. The ESPB group received ESPB plus intravenous analgesia, while the control group received intravenous analgesia only. Since ESPB was performed during GA, the control group did not receive any placebo to simulate ESPB.