دورية أكاديمية

Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial.

التفاصيل البيبلوغرافية
العنوان: Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial.
المؤلفون: De la Gala F; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Piñeiro P; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain. bagullo76@hotmail.com., Reyes A; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Simón C; Department Thoracic Surgery, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Vara E; Biochemical Department, School of Medicine, Universidad Complutense de Madrid, Madrid, Spain., Rancan L; Biochemical Department, School of Medicine, Universidad Complutense de Madrid, Madrid, Spain., Huerta LJ; Department Thoracic Surgery, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Gonzalez G; Department Thoracic Surgery, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Benito C; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Muñoz M; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Grande P; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Paredes SD; Biochemical Department, School of Medicine, Universidad Complutense de Madrid, Madrid, Spain., Aznar PT; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Perez A; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Martinez D; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Higuero F; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Sanz D; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., De Miguel JP; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Cruz P; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Olmedilla L; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Lopez Gil E; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Duque P; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Sanchez-Pedrosa G; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Valle M; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain., Garutti I; Department Anesthesiology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
المصدر: Trials [Trials] 2019 Nov 06; Vol. 20 (1), pp. 622. Date of Electronic Publication: 2019 Nov 06.
نوع المنشور: Comparative Study; Journal Article; Randomized Controlled Trial
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Anesthetics, Local/*administration & dosage , Lidocaine/*administration & dosage , Pneumonectomy/*methods , Postoperative Complications/*epidemiology, Double-Blind Method ; Enhanced Recovery After Surgery ; Humans ; Infusions, Intravenous ; Perioperative Care ; Thoracoscopy
مستخلص: Background: Use of minimally invasive surgical techniques for lung resection surgery (LRS), such as video-assisted thoracoscopy (VATS), has increased in recent years. However, there is little information about the best anesthetic technique in this context. This surgical approach is associated with a lower intensity of postoperative pain, and its use has been proposed in programs for enhanced recovery after surgery (ERAS). This study compares the severity of postoperative complications in patients undergoing LRS who have received lidocaine intraoperatively either intravenously or via paravertebral administration versus saline.
Methods/design: We will conduct a single-center randomized controlled trial involving 153 patients undergoing LRS through a thoracoscopic approach. The patients will be randomly assigned to one of the following study groups: intravenous lidocaine with more paravertebral thoracic (PVT) saline, PVT lidocaine with more intravenous saline, or intravenous remifentanil with more PVT saline. The primary outcome will be the comparison of the postoperative course through Clavien-Dindo classification. Furthermore, we will compare the perioperative pulmonary and systemic inflammatory response by monitoring biomarkers in the bronchoalveolar lavage fluid and blood, as well as postoperative analgesic consumption between the three groups of patients. We will use an ANOVA to compare quantitative variables and a chi-squared test to compare qualitative variables.
Discussion: The development of less invasive surgical techniques means that anesthesiologists must adapt their perioperative management protocols and look for anesthetic techniques that provide good analgesic quality and allow rapid rehabilitation of the patient, as proposed in the ERAS protocols. The administration of a continuous infusion of intravenous lidocaine has proven to be useful and safe for the management of other types of surgery, as demonstrated in colorectal cancer. We want to know whether the continuous administration of lidocaine by a paravertebral route can be substituted with the intravenous administration of this local anesthetic in a safe and effective way while avoiding the risks inherent in the use of regional anesthetic techniques. In this way, this technique could be used in a safe and effective way in ERAS programs for pulmonary resection.
Trial Registration: EudraCT, 2016-004271-52; ClinicalTrials.gov, NCT03905837 . Protocol number IGGFGG-2016 version 4.0, 27th April 2017.
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معلومات مُعتمدة: 99.220 Euros Instituto de Salud Carlos III. Ministerio de Sanidad España
فهرسة مساهمة: Keywords: Lidocaine; Lung resection surgery; Postoperative complications; Postoperative pulmonary complications
سلسلة جزيئية: ClinicalTrials.gov NCT03905837
المشرفين على المادة: 0 (Anesthetics, Local)
98PI200987 (Lidocaine)
تواريخ الأحداث: Date Created: 20191108 Date Completed: 20200427 Latest Revision: 20200427
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC6836654
DOI: 10.1186/s13063-019-3677-9
PMID: 31694684
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-019-3677-9