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NCT03905837

Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery

Completed Phase 4 Last updated 25 August 2021
What this trial tests

Phase 4 trial testing Lidocaine in Lung Diseases in 156 participants. Completed in 2 July 2021.

Timeline
28 January 2019
Primary endpoint
2 June 2021
2 July 2021

Quick facts

Lead sponsorFrancisco Andres de la Gala
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment156
Start date28 January 2019
Primary completion2 June 2021
Estimated completion2 July 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Francisco Andres de la Gala — full company profile →

Who can join

18 and older, any sex, with Lung Diseases or Lung Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effect of intraoperative paravertebral or intravenous lidocaine versus control during lung resection surgery on postoperative complications: A randomized controlled trial.
    De la Gala F, Piñeiro P, Reyes A, Simón C, et al · · 2019 · cited 6× · PMID 31694684 · DOI 10.1186/s13063-019-3677-9
  2. Effect of intraoperative paravertebral or intravenous lidocaine infusion on postoperative complications and inflammation after lung resection surgery: a randomised controlled trial.
    de la Gala F, de la Fuente E, Piñeiro P, Reyes A, et al · · 2025 · cited 2× · PMID 40897588 · DOI 10.1016/j.bja.2025.05.059
  3. Impact of Intraoperative Lidocaine During Oncologic Lung Resection on Long-Term Outcomes in Primary Lung Cancer: A Post Hoc Analysis of a Randomized Controlled Trial.
    de la Fuente E, de la Gala F, Hortal J, Simón C, et al · · 2025 · cited 1× · PMID 40941021 · DOI 10.3390/cancers17172923
  4. High Cerebral Oxygen Saturation Levels During One-Lung Ventilation Predict Better Cognitive and Clinical Outcomes After Thoracic Surgery: A Retrospective Observational Study.
    Garutti I, de la Gala F, Hortal J, Reyes A, et al · · 2025 · PMID 41003148 · DOI 10.3390/jpm15090445

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Data sources for this page

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