110787 20230519145519.0 doi 10.1186/s13063-021-05216-6 sideral 127444 ART-2021-127444 eng Oliver Fornies, Pablo Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind Redole 2021 Access copy available to the general public Unrestricted Background: Arthroscopic shoulder surgery causes severe postoperative pain. An interscalene brachial plexus block provides adequate analgesia, but unintended spread of the local anesthetic administered may result in a phrenic nerve block, usually associated with a nonnegligible incidence of acute hemidiaphragmatic paralysis. The main purpose of this trial will be to analyze the incidence of hemidiaphragmatic paralysis ensuing after interscalene brachial plexus block in patients undergoing arthroscopic shoulder surgery administered a standard volume (20 ml) vs. a low volume (10 ml) of levobupivacaine 0.25%. Methods: This will be a prospective double-blind randomized controlled single-center two-arm comparative trial. Forty-eight patients will be included. The primary goal will be to ultrasonographically determine the incidence of hemidiaphragmatic paralysis by calculating the diaphragmatic thickness ratio in each group. The secondary goals will be to compare the two arms in terms of (1) decrease in forced vital capacity and (2) in forced expiratory volume at 1 s by spirometry; (3) decrease in diaphragmatic excursion by ultrasound; (4) 24-h total intravenous morphine consumption; (5) time to first opioid request of a patient-controlled analgesia pump; and (6) postoperative complications. Discussion: This trial will demonstrate that a low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis following arthroscopic shoulder surgery according to spirometry and ultrasound measurements and does not provide inferior postoperative analgesia to the standard volume, as measured by opioid requirements. Trial registration: EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (registered on 7 January 2020). ClinicalTrials.gov identification number: NCT04385966 (retrospectively registered on 8 May 2020). Ethics Committee approval: EC19/093 (18 December 2019). info:eu-repo/semantics/openAccess by http://creativecommons.org/licenses/by/3.0/es/ 2.728 2021 MEDICINE, RESEARCH & EXPERIMENTAL 106 / 140 = 0.757 2021 Q4 T3 0.865 2021 Pharmacology (medical) 2021 Q1 Medicine (miscellaneous) 2021 Q1 3.4 2021 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Ortega Lahuerta, J. P. Gomez Gomez, R. Gonzalo Pellicer, I. Oliden Gutierrez, L. Viñuales Cabeza, J. Gallego Ligorit, L. Universidad de Zaragoza Orellana Melgar, C. E. 1013 090 Universidad de Zaragoza Dpto. Cirugía Área Cirugía 22, 287 (2021), 1-12 Trials Trials 1745-6215 595565 http://zaguan.unizar.es/record/110787/files/texto_completo.pdf Versión publicada 2033842 http://zaguan.unizar.es/record/110787/files/texto_completo.jpg?subformat=icon icon Versión publicada oai:zaguan.unizar.es:110787 articulos driver 2023-05-18-15:21:23 ARTICLE