000110787 001__ 110787 000110787 005__ 20230519145519.0 000110787 0247_ $$2doi$$a10.1186/s13063-021-05216-6 000110787 0248_ $$2sideral$$a127444 000110787 037__ $$aART-2021-127444 000110787 041__ $$aeng 000110787 100__ $$aOliver Fornies, Pablo 000110787 245__ $$aDiaphragmatic 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 000110787 260__ $$c2021 000110787 5060_ $$aAccess copy available to the general public$$fUnrestricted 000110787 5203_ $$aBackground: 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). 000110787 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/ 000110787 590__ $$a2.728$$b2021 000110787 592__ $$a0.865$$b2021 000110787 594__ $$a3.4$$b2021 000110787 591__ $$aMEDICINE, RESEARCH & EXPERIMENTAL$$b106 / 140 = 0.757$$c2021$$dQ4$$eT3 000110787 593__ $$aPharmacology (medical)$$c2021$$dQ1 000110787 593__ $$aMedicine (miscellaneous)$$c2021$$dQ1 000110787 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000110787 700__ $$aOrtega Lahuerta, J. P. 000110787 700__ $$aGomez Gomez, R. 000110787 700__ $$aGonzalo Pellicer, I. 000110787 700__ $$aOliden Gutierrez, L. 000110787 700__ $$aViñuales Cabeza, J. 000110787 700__ $$aGallego Ligorit, L.$$uUniversidad de Zaragoza 000110787 700__ $$aOrellana Melgar, C. E. 000110787 7102_ $$11013$$2090$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Cirugía 000110787 773__ $$g22, 287 (2021), 1-12$$pTrials$$tTrials$$x1745-6215 000110787 8564_ $$s595565$$uhttps://zaguan.unizar.es/record/110787/files/texto_completo.pdf$$yVersión publicada 000110787 8564_ $$s2033842$$uhttps://zaguan.unizar.es/record/110787/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000110787 909CO $$ooai:zaguan.unizar.es:110787$$particulos$$pdriver 000110787 951__ $$a2023-05-18-15:21:23 000110787 980__ $$aARTICLE