drugset / Trial / NCT03905837
Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery
RandomizedParallel-groupQuadruple-blindPrevention
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.
Timeline
- Start
- 2019-01-28
- Primary completion
- 2021-06-02
- Completion
- 2021-07-02
Publications
- de la Gala F, de la Fuente E, Pineiro P, Reyes A, Duque P, Sanchez-Pedrosa G, Martinez-Gascuena D, Vara E, Rancan L, Simon C, Hortal J, Garutti I. Effect of intraoperative paravertebral or intravenous lidocaine infusion on postoperative complications and inflammation after lung resection surgery: a randomised controlled trial. Br J Anaesth. 2025 Nov;135(5):1297-1306. doi: 10.1016/j.bja.2025.05.059. Epub 2025 Sep 1.
- De la Gala F, Pineiro P, Reyes A, Simon C, Vara E, Rancan L, Huerta LJ, Gonzalez G, Benito C, Munoz M, Grande P, Paredes SD, Aznar PT, Perez A, Martinez D, Higuero F, Sanz D, De Miguel JP, Cruz P, Olmedilla L, Lopez Gil E, Duque P, Sanchez-Pedrosa G, Valle M, Garutti I. Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial. Trials. 2019 Nov 6;20(1):622. doi: 10.1186/s13063-019-3677-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 0.1 ml | Intravenous |
| Subject | Lidocaine | Other / unclassified | 1.5 mg/kg | Intravenous |
| Subject | Lidocaine | Other / unclassified | 2 % | Intravenous |
| Comparator | Remifentanil | Small molecule | 0.1 mg/kg | Intravenous |