Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial
Francisco De la Gala,
Patricia Piñeiro,
Almudena Reyes,
Carlos Simón,
Elena Vara,
Lisa Rancan,
Luis Javier Huerta,
Guillermo Gonzalez,
Carmen Benito,
Marta Muñoz,
Pilar Grande,
Sergio D. Paredes,
Pablo Tomas Aznar,
Alvaro Perez,
David Martinez,
Fernando Higuero,
David Sanz,
Juan Pedro De Miguel,
Patricia Cruz,
Luis Olmedilla,
Elena Lopez Gil,
Patricia Duque,
Guillermo Sanchez-Pedrosa,
Mayte Valle,
Ignacio Garutti
Affiliations
Francisco De la Gala
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Patricia Piñeiro
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Almudena Reyes
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Carlos Simón
Department Thoracic Surgery, Hospital General Universitario Gregorio Marañón
Elena Vara
Biochemical Department, School of Medicine, Universidad Complutense de Madrid
Lisa Rancan
Biochemical Department, School of Medicine, Universidad Complutense de Madrid
Luis Javier Huerta
Department Thoracic Surgery, Hospital General Universitario Gregorio Marañón
Guillermo Gonzalez
Department Thoracic Surgery, Hospital General Universitario Gregorio Marañón
Carmen Benito
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Marta Muñoz
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Pilar Grande
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Sergio D. Paredes
Biochemical Department, School of Medicine, Universidad Complutense de Madrid
Pablo Tomas Aznar
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Alvaro Perez
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
David Martinez
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Fernando Higuero
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
David Sanz
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Juan Pedro De Miguel
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Patricia Cruz
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Luis Olmedilla
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Elena Lopez Gil
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Patricia Duque
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Guillermo Sanchez-Pedrosa
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Mayte Valle
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Ignacio Garutti
Department Anesthesiology, Hospital General Universitario Gregorio Marañón
Abstract 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.