Impact of Lidocaine Administration on Postoperative Complications During Lung Resection Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2021-07-02

Brief Summary

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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.

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Detailed Description

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Postoperative pulmonary complications continue to be one of the main causes of morbidity, mortality and increase in hospital stay in patients undergoing surgical procedures requiring anesthesia. Its incidence in lung resection surgery is greater than in other non-cardiac major surgeries due to damage of structures related to respiratory function.

Furthermore, during lung resection surgery there is an exaggerated pulmonary inflammatory response related to the use of one-lung ventilation and / or the lung damage produced by the collapse of the operated lung as well as the surgical manipulation itself.

Recently, in a clinical trial on 180 patients (NCT 02168751), our researcher group observed that the attenuation of the pulmonary inflammatory response through the use of halogenated anesthetic agents, was related to a decrease in the appearance of postoperative pulmonary complications after lung resection surgery. In addition, the presence, in bronchoalveolar lavages, of elevated levels of tumor necrosis factor-alpha, interleukine(IL)-6 and the IL-6 / IL10 ratio were independent predictors of the risk of developing postoperative pulmonary complications.

Lidocaine is a local anesthetic that blocks nerve conduction by blocking sodium channels. In addition it has been known for experimental and clinical studies of its immunomodulatory properties.

Clinical studies performed in different surgeries show that a continuous intravenous infusion of lidocaine during surgery is associated with a lower inflammatory response assessed by monitoring plasma cytokines, as well as less postoperative pain, a shorter duration of postoperative paralytic ileus and a early hospital discharge.

Currently, there is no clinical study that has evaluated the role of intravenous lidocaine on the pulmonary inflammatory response and the subsequent lung damage that inevitably occurs during lung resection surgery with periods of one lung ventilation.

Currently, some experts are proposing the replacement of thoracic epidural and paravertebral analgesia by the intravenous infusion of lidocaine and minor analgesics, for fast-track programs, based on their analgesic and anti-inflammatory capacity and on avoiding the risks inherent in the insertion of an epidural or paravertebral catheter.

Hypothesis: The administration of intravenous or paravertebral lidocaine during lung resection surgery attenuates the exaggerated inflammatory response that inevitably occurs in this surgical intervention. The lower expression of pro-inflammatory mediators will be associated with a lower rate of postoperative complications that are related to the perioperative inflammatory process.

Conditions

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Lung Diseases Lung Inflammation Lung Injury, Acute Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Lidocaine IV

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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Intravenous or paravertebral lidocaine

Lidocaine PV

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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Intravenous or paravertebral lidocaine

no lidocaine

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.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

intravenous remifentanil

Interventions

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Lidocaine

Intravenous or paravertebral lidocaine

Intervention Type DRUG

Remifentanil

intravenous remifentanil

Intervention Type DRUG

Other Intervention Names

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Lignocaine N-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide methyl 1-(2-methoxycarbonylethyl)-4-(phenyl-propanoyl-amino)-piperidine-4-carboxylate

Eligibility Criteria

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Inclusion Criteria

* 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No