Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery

NCT03905837 | Completed Phase 4

• 1 other identifier: IGMFGG-2016
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lidocaine; postoperative complications; thoracic surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  to compare the proportion of patients included in the different scales of the Clavien-Dindo classification of postoperative complications reviewed for thoracic surgery in the three groups of patients. Patients will be followed from the day of hospital admission until hospital discharge and up to 30 days after the surgery

  up to 30 days after intervention

Secondary Outcomes (10)

• gas exchange

  24 hours

• Differences between three groups in Inflammatory biomarkers (IL 1, IL 2, IL 6, IL 8, IL 10, TNF alpha, MCP-1) measure in serum and bronchoalveolar lavage during 24 hours after the surgery.

  up to 24 hours of intervention

• Analgesic requirements of opioids in the first 24 hours after the surgery

  24 hours

• Special Care Units stay

  up to 30 days after intervention

• Hospital stay

  up to 30 days after intervention

Study Arms (3)

Lidocaine IV

EXPERIMENTAL

Group 1: intravenous lidocaine and paravertebral saline (SF). In this group during intraoperative anesthetic maintenance, a continuous intravenous infusion of lidocaine at 1.5mg/kg/h until the end of surgery and perfusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1ml/kg/h will be administered.

Drug: Lidocaine

Lidocaine PV

EXPERIMENTAL

Group 2: intravenous SF and paravertebral lidocaine. During anesthesia maintenance, a continuous intravenous infusion of 0.9% SF and an infusion of 2% lidocaine will be administered through the intraoperative paravertebral catheter at a rate of 0.1 ml/kg/h.

Drug: Lidocaine

no lidocaine

ACTIVE COMPARATOR

Group 3: intravenous remifentanil and paravertebral SF. During the maintenance of anesthesia, a continuous intravenous infusion of remifentanil at a rate of 0.1 mg/kg/min until the end of surgery and an infusion of 0.9% SF through the intraoperative paravertebral catheter at a rate of 0.1 ml / kg / h.

Drug: Remifentanil

Interventions

Lidocaine DRUG

Intravenous or paravertebral lidocaine

Also known as: Lignocaine, N-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide

Lidocaine IV; Lidocaine PV

Remifentanil DRUG

intravenous remifentanil

Also known as: methyl 1-(2-methoxycarbonylethyl)-4-(phenyl-propanoyl-amino)-piperidine-4-carboxylate

no lidocaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes undergoing lung resection surgery at the Thoracic Surgery Service at the Gregorio Maranón 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francisco Andres de la Gala: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Hospital Gregorio Maranon

Madrid, 28007, Spain

Location

Related Publications (2)

• 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.

  PMID: 40897588 DERIVED

• 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.

  PMID: 31694684 DERIVED

MeSH Terms

Conditions

Lung Diseases; Pneumonia; Acute Lung Injury; Postoperative Complications

Interventions

Lidocaine; Remifentanil

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Lung Injury; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Francisco de la Gala, MD PhD

  Hospital Gregorio Maranon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization will be carried out through the EPIDAT 3.1 program. Randomization codes will be obtained prior to the recruitment of the first patient and will be kept in a sealed envelope with numbering on the outside of the envelope. The operating room anesthesiologist will receive the assigned medication from the corresponding group with the only identification of intravenous perfusion and paravertebral perfusion, without having knowledge of the group to which the patient belongs. Bias control: The anesthesiologist responsible for the intraoperative management of the patient, the physician responsible for postoperative control in the postoperative care unit and the guard physician who will perform the cognitive dysfunction test preoperative and postoperative and the follow up until the month of surgery will be blind to the technique used, as well as those responsible for the analysis of the biological samples.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist. MD. PhD

Model Details: Unicentric, randomized, blind and controlled phase IV Clinical trial of three parallel groups. Randomization: Patients will be randomized into three groups (ratio 1: 1: 1): intravenous lidocaine and paravertebral saline (group 1), intravenous and paravertebral saline solution with lidocaine (group 2) and intravenous remifentanil and paravertebral saline solution (group 3) ). The randomization will be carried out through the EPIDAT 3.1 program prior to the recruitment of the first patient and the randomization codes will be kept in a sealed envelope with the number on the outside of the envelope. Patients will be followed from the day of hospital admission until hospital discharge and after 30 days of surgery.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 5, 2019
• Study Start: January 28, 2019
• Primary Completion: June 2, 2021
• Study Completion: July 2, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

ES (1)