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
| Autor: | L. Gallego Ligorit, Pablo Oliver-Fornies, J. P. Ortega Lahuerta, L. Oliden Gutierrez, R. Gomez Gomez, I. Gonzalo Pellicer, C. E. Orellana Melgar, J. Viñuales Cabeza |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Arthroscopic shoulder surgery
Medicine (General) Shoulder Shoulder surgery medicine.drug_class medicine.medical_treatment Medicine (miscellaneous) Diaphragmatic breathing Diaphragmatic paralysis Postoperative pain Study Protocol Arthroscopy 03 medical and health sciences R5-920 0302 clinical medicine Double-Blind Method 030202 anesthesiology Ultrasound medicine Paralysis Humans Pharmacology (medical) Respiratory function Prospective Studies Anesthetics Local Levobupivacaine Randomized Controlled Trials as Topic Pain Postoperative Local anesthetic business.industry Brachial Plexus Block Respiratory Paralysis Spirometry Randomized controlled trial Interscalene brachial plexus block Anesthesia medicine.symptom Diaphragmatic excursion business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Zaguán. Repositorio Digital de la Universidad de Zaragoza instname Trials Trials, Vol 22, Iss 1, Pp 1-12 (2021) |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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