Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk

ConditionsNon-Small Cell Lung Cancer Recurrence Survival Analysis

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorFirst Affiliated Hospital of Ningbo University

About this trial

The goal of this clinical trial is to explore if perioperative lidocaine infusion decreases disease reoccurrence and metastasis risk in non-small cell lung cancer patients.

Participants will be randomly assigned (1:1) to the lidocaine or placebo group. The intervention initiates within 30 minutes before anesthesia induction with an intravenous loading dose of 1.5 mg/kg administered over 10-20 minutes. This is followed by a continuous maintenance infusion of 1.5-3 mg/kg/h (calculated as 1-1.5 mg/kg/h in protocol text, see note below) during surgery, terminating 1 hour after skin closure. Participants will be followed up for 36 months post-surgery. Blood samples will be collected at baseline, postoperative day 1, day 3, and upon discharge

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age range: 18-80 years old.

Electively undergo minimally invasive (thoracoscopic or robotic) surgery for the treatment of lung cancer

Is willing and capable of providing consent.

Disqualifiers

Palliative surgery without intention of cure.

Extensive comorbidities (ASA IV).

Patients with known or suspected allergy to lidocaine.

Patients who are currently pregnant or breastfeeding.

Trial design

Design model

Parallel

Treatments tested in this trial

Lidocaine (drug)
Drug
According to the random number table, grouping and coding are set, and the coding rules are predetermined by the statistical analyst. The intervention information is placed in a sealed opaque envelope and managed by an independent randomization specialist. After signing the informed consent form, the randomization specialist will configure drugs based on the grouping information and label them with codes, and hand them over to the anesthesiologist conducting blind intervention operations

Treatment groups

1,400 Participants

are divided into 2 treatment groups

Group A: lidocine infusion groupExperimental treatment 1 intervention

Group B: normal saline groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Disease-Free Survival (DFS)

DFS is defined as the time from the date of surgery to the first documentation of disease recurrence (including local recurrence, regional lymph node metastasis, or distant metastasis) or death from any cause.

Time frame

Up to 36 months after operation

Secondary outcomes

Overall Survival (OS)

Overall survival is defined as the time from randomization to death from any cause

Time frame

36month after operation

EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)

The EQ-5D-5L is used to assess health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L index score is calculated using population-based preference weights and typically ranges from less than 0 (health states worse than death) to 1 (full health), with higher scores indicating better health-related quality of life.In addition, the EQ Visual Analogue Scale (EQ-VAS) records the participant's self-rated health on a vertical scale ranging from 0 (worst imaginable health) to 100 (best imaginable health), with higher scores indicating better perceived health.

Time frame

Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery

Cancer-specific quality of life measured using the Functional Assessment of Cancer Therapy - Lung (FACT-L)

The FACT-L is a validated instrument that includes the Functional Assessment of Cancer Therapy - General (FACT-G) and a lung cancer-specific subscale. The total FACT-L score ranges from 0 to 136, with higher scores indicating better cancer-specific quality of life.

Time frame

Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery

Other outcomes

Total length of hospital stay

Total length of hospital stay, including readmission, up to 36 months

Time frame

Up to 36 months

Changes in Serum Biomarkers

Changes in pro-inflammatory cytokine levels (e.g., interleukin-6 \[IL-6\], tumor necrosis factor-alpha \[TNF-α\], matrix metalloproteinase-9 \[MMP-9\], and matrix metalloproteinase-2 \[MMP-2\]) from baseline.

Time frame

Baseline, postoperative Day 1, postoperative Day 3, and at hospital discharge (assessed up to 5 days postoperatively).

Incidence of Perioperative Adverse Events and Pain Scores

Assessment of perioperative complications including nausea, vomiting, and delirium, as well as pain intensity assessed using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.

Time frame

From the end of surgery up to hospital discharge (approximately 7-10 days)

Incidence of Cardiovascular Events

Documentation of any new-onset cardiovascular events (e.g., arrhythmia, myocardial infarction) occurring after treatment.

Time frame

At 6 months and 12 months post-surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Ningbo University

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

Source ClinicalTrials.gov

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