Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk

NCT07347977 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Ningbo University

Phase

Not applicable

Started

2026-01-01

Last updated

2026-01-16

Condition(s) studied

Non-Small Cell Lung CancerRecurrenceSurvival Analysis

Investigational drug(s) / intervention(s)

Lidocaine (drug) →

Lidocaine (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

Study summary

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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age range: 18-80 years old. 2. Electively undergo minimally invasive (thoracoscopic or robotic) surgery for the treatment of lung cancer 3. Is willing and capable of providing consent. Exclusion Criteria: 1. Palliative surgery without intention of cure. 2. Extensive comorbidities (ASA IV). 3. Patients with known or suspected allergy to lidocaine. 4. Patients who are currently pregnant or breastfeeding. 5. Patients who may experience adverse reactions due to accumulation of lidocaine during intravenous infusion, as stated in the Summary of Product Characteristics (SmPC) for lidocaine. 6. Currently, there is abnormal liver function, with ALT or AST levels exceeding the laboratory reference range by a factor of 2. 7. Currently, there is severe renal insufficiency (serum creatinine ≥451umol/L or glomerular filtration rate (calculated using the MDRD formula) \<30ml/min). 8. Epilepsy. 9. Patients with cardiac conduction abnormalities, including second-degree or third-degree heart block without a pacemaker, left bundle branch block, sick sinus syndrome, and pre-excitation syndrome (confirmed by medical history and electrocardiogram), as well as those with low cardiac output due to reduced left ventricular ejection fraction. 10. Concurrent use with continuous infusion of other local anesthetic drugs (such as epidural). 11. Patients who use drugs that may cause reasons for exclusion, including Class I and Class III antiarrhythmic drugs (such as mexiletine and amiodarone), cimetidine, and antiviral drugs. Eligibility will be determined by local clinicians and verified by clinical trial doctors. 12. Patients with body weight \<40kg

Primary outcome measure(s)

Disease-Free Survival (DFS) — Up to 36 months after operation
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.

Trial sites (1)

Facility	City	Region	Status
The first affiliated hospital of Ningbo University	Ningbo	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07347977 on ClinicalTrials.gov ↗ ← All trials in China