Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk (LidCRM)

January 11, 2026 updated by: Changshun Huang, MD, First Affiliated Hospital of Ningbo University

Lidocaine Infusion Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk: a Multicenter Randomized Controlled Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Research design: This is a 1:1 parallel, double-blind (participants, investigators, and outcomes assessors) randomized controlled trial. Intravenous lidocaine or saline will be assigned to patients with lung cancer undergoing minimally invasive (thoracoscopic or robotic) surgery.

  2. Research Methods:

    2.1. Intervention: 2% lidocaine hydrochloride or placebo (0.9% sodium chloride).

    2.2. Dose planning: The intervention initiates within 30 minutes before anesthesia induction with an intravenous loading dose of 1.5 mg/kg (ideal body weight, IBW) administered over 10-20 minutes. This is followed by a continuous maintenance infusion of 1-1.5 mg/kg/h during surgery, terminating 1 hour after skin closure. The maximum infusion rate is capped at 120 mg/h. IBW is used to calculate dosage to prevent toxicity in overweight patients; however, for patients weighing less than their IBW, actual body weight is used. Patients in the placebo group receive the same volume and rate as the treatment group.

    Dose Guidelines Based on IBW (Broca Index): Males: height (cm) - 100; Females: height (cm) - 105.

    2.3. Dose adjustment: No dosage changes are permitted. If systemic local anesthetic toxicity is suspected, the infusion must be stopped immediately and not resumed. Supportive care and lipid emulsion therapy will be provided. If infusion is interrupted due to mechanical issues (e.g., pump malfunction), it may be restarted at the original rate.

    2.4. Additional care and procedures: To minimize confounding, general anesthesia will be maintained using a balanced technique. Postoperative care follows the unit's standard Enhanced Recovery After Surgery (ERAS) protocol. Concurrent continuous infusion of other local anesthetics (e.g., epidural or wound catheters) is prohibited during the IMP infusion period.

    2.5. Postoperative analgesia management: After surgery, all patients will receive intravenous patient-controlled analgesia (or continuous infusion) with sufentanil (2 µg/kg diluted to 100 ml) at a background rate of 2 ml/h.

    2.6. Sample size calculation: Based on a median recurrence-free survival (RFS) of 18 months in the control group and an expected extension to 24 months in the treatment group, the estimated Hazard Ratio (HR) is 0.75 (representing a 25% risk reduction). With a two-sided alpha of 0.05 and 90% power, 635 patients per group are required. Adjusting for a 10% dropout rate, the total sample size is set at 1400 patients (700 per group).

    2.7. Randomization: Participants will be randomly assigned (1:1) using a minimization algorithm. Stratification factors include age (<45, 45-65, 65-80 years), gender, trial center, and pathological type of lung cancer.

  3. Efficacy evaluation criteria: The primary efficacy endpoint is Disease-Free Survival (DFS) within 36 months post-surgery. Chest CT scans will be performed at 6, 12, 18, 24, and 36 months to assess recurrence or metastasis. Additionally, the FACT-L questionnaire will be used to assess cancer-specific quality of life.
  4. Adverse events: The lidocaine dose and duration in this study align with international consensus statements on safety. The infusion is limited to the intraoperative period and ends 1 hour post-skin closure, minimizing accumulation risks. Safety monitoring will be conducted throughout the infusion. In the event of toxicity, lipid emulsion (20%) is available for immediate rescue following AAGBI guidelines.
  5. Quality control and quality assurance: SOPs will be strictly followed. Since the IMP infusion ends 1 hour after skin closure, monitoring will primarily occur in the operating room and PACU. Data will be recorded using EDC software. The investigators aim to collect outcome data for all randomized participants according to the intention-to-treat principle.

  6. Statistical analysis: Data will be analyzed using SPSS 21 based on the intention-to-treat (ITT) principle.

    Primary Analysis: The primary outcome (DFS at 36 months) will be analyzed using a multivariate Cox regression model to estimate the Hazard Ratio (HR) between the lidocaine and placebo groups, adjusting for covariates.

    Covariates: Age, gender, comorbidities, ASA classification, cancer stage, and neoadjuvant therapies.

    Survival Analysis: Kaplan-Meier curves and Log-rank tests will be used to compare survival distributions.

    Missing Data: Missing data will be handled using multiple imputation to ensure robustness.

  7. Ethics: The study adheres to the Declaration of Helsinki and local regulations. Ethics committee approval is required prior to initiation. Written informed consent will be obtained from all participants, ensuring they understand the risks and their right to withdraw. Privacy and data confidentiality will be strictly maintained.

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • The First Affiliated Hospital of Ningbo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lidocine infusion group
Lidocaine is administered intravenously at an ideal body weight (IBW) of 1.5 mg/kg starting from anesthesia induction, for 10-20 minutes, and then continuously infused at 1-1.5 mg/kg/h until 1 hour after skin closure, with a maximum rate of 120 mg/h. Use ideal weight instead of actual weight to prevent toxicity in very overweight patients. In patients with a weight lower than the ideal weight, the actual weight should be used to calculate the dose.
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
Other Names:
  • Lidocaine IV
Placebo Comparator: normal saline group
The normal saline is administered at the volume calculated based on the equivalent volume of lidocaine dose according to body weight
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
Other Names:
  • Lidocaine IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: 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.
Up to 36 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 36month after operation
Overall survival is defined as the time from randomization to death from any cause
36month after operation
EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Time Frame: Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery

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.
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)
Time Frame: Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery
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.
Baseline, Postoperative Day 1, Day 3, Discharge, and at 6, 12, 18, 24, 36 months post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total length of hospital stay
Time Frame: Up to 36 months
Total length of hospital stay, including readmission, up to 36 months
Up to 36 months
Changes in Serum Biomarkers
Time Frame: Baseline, postoperative Day 1, postoperative Day 3, and at hospital discharge (assessed up to 5 days postoperatively).
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.
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
Time Frame: From the end of surgery up to hospital discharge (approximately 7-10 days)
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.
From the end of surgery up to hospital discharge (approximately 7-10 days)
Incidence of Cardiovascular Events
Time Frame: At 6 months and 12 months post-surgery
Documentation of any new-onset cardiovascular events (e.g., arrhythmia, myocardial infarction) occurring after treatment.
At 6 months and 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Ningbo University

Collaborators

Ningbo Medical Center Lihuili Hospital
Second Affiliated Hospital of Wenzhou Medical University
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Investigators

  • Principal Investigator: Changshun Huang, MD, First Affiliated Hospital of Ningbo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

December 30, 2029

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025B024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) may not be shared because the informed consent does not include provisions for public data sharing, and data are subject to institutional and ethical review restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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