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Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery

NCT03905837 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2021-08-25

No results posted yet for this study

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.

Conditions

  • Lung Diseases
  • Lung Inflammation
  • Lung Injury, Acute
  • Postoperative Complications

Interventions

DRUG

Lidocaine

Intravenous or paravertebral lidocaine

DRUG

Remifentanil

intravenous remifentanil

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Francisco Andres de la Gala

    lead OTHER

Principal Investigators

  • Francisco de la Gala, MD PhD · Hospital Gregorio Maranon

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2021-06-02
Completion
2021-07-02

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03905837 on ClinicalTrials.gov