Overview

Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery

Status:
Completed
Trial end date:
2021-07-02
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to analyze the impact of the intravenous (IV) or paravertebral (PV) lidocaine administration during the intraoperative period of lung resection surgery on the appearance of postoperative complications. We design a randomized, controlled and blinded study to be performed in 153 patients with 3 arms: 1) Lidocaine IV + PV saline 2) saline IV + PV lidocaine, 3) remifentanil IV + PV saline. Perioperative analysis of inflammatory biomarkers in bronchoalveolar lavage and serum. Follow-up of the postoperative course, especially the appearance of postoperative complications according to the revised Clavien-Dindo classification for thoracic surgery, as well as other relevant clinical results.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Francisco Andres de la Gala
Collaborator:
Instituto de Salud Carlos III
Treatments:
Lidocaine
Piperidine
Remifentanil
Criteria
Inclusion Criteria:

- Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery
Service at the Gregorio MaranĂ³n hospital.

- Patients who voluntarily accept to participate in the study and sign the informed
consent

- Age> 18 years and legally capable

- Scheduled surgery.

- Functional respiratory tests with forced expiratory volume at one second > 50% or
forced vital capacity > 50% preoperatively performed on these patients routinely.

- Not having been on chronic treatment with oral corticosteroids or immunosuppressants
three months before surgery.

- Patients without previous history of liver disease.

Exclusion Criteria:

- Pregnancy and lactation

- Known hypersensitivity to amide-type local anesthetics.

- Transfusion of blood products in the previous 10 days.

- Impossibility of performing mechanical ventilation for pulmonary protection.