Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk

NCT07347977 | Not Yet Recruiting DMC

• 1 other identifier: 2025B024
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-Small Cell Lung Cancer; Recurrence; Survival Analysis

Keywords

Lidocaine; Non-small cell lung cancer; Recurrence; Survival analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 36 months after operation

Secondary Outcomes (3)

• Overall Survival (OS)

  36month after operation

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

  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)

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

Other Outcomes (4)

• Total length of hospital stay

  Up to 36 months

• Changes in Serum Biomarkers

  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

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

Study Arms (2)

lidocine infusion group

EXPERIMENTAL

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)

normal saline group

PLACEBO COMPARATOR

The normal saline is administered at the volume calculated based on the equivalent volume of lidocaine dose according to body weight

Drug: Lidocaine (drug)

Interventions

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

Also known as: Lidocaine IV

lidocine infusion group; normal saline group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Currently, there is abnormal liver function, with ALT or AST levels exceeding the laboratory reference range by a factor of 2.
• Currently, there is severe renal insufficiency (serum creatinine ≥451umol/L or glomerular filtration rate (calculated using the MDRD formula) \<30ml/min).
• Epilepsy.
• 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.
• Concurrent use with continuous infusion of other local anesthetic drugs (such as epidural).
• Patients with body weight \<40kg

Sponsors & Collaborators

• First Affiliated Hospital of Ningbo University: lead
• 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

Study Sites (1)

The first affiliated hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

Location

Related Publications (12)

• Hiller JG, Perry NJ, Poulogiannis G, Riedel B, Sloan EK. Perioperative events influence cancer recurrence risk after surgery. Nat Rev Clin Oncol. 2018 Apr;15(4):205-218. doi: 10.1038/nrclinonc.2017.194. Epub 2017 Dec 28.

  PMID: 29283170 RESULT

• Ben-Eliyahu S, Golan T. Harnessing the Perioperative Period to Improve Long-term Cancer Outcomes. J Natl Cancer Inst. 2018 Oct 1;110(10):1137-1138. doi: 10.1093/jnci/djy055. No abstract available.

  PMID: 29718287 RESULT

• Wall TP, Buggy DJ. Perioperative Intravenous Lidocaine and Metastatic Cancer Recurrence - A Narrative Review. Front Oncol. 2021 Aug 2;11:688896. doi: 10.3389/fonc.2021.688896. eCollection 2021.

  PMID: 34408981 RESULT

• Zhang L, Hu R, Cheng Y, Wu X, Xi S, Sun Y, Jiang H. Lidocaine inhibits the proliferation of lung cancer by regulating the expression of GOLT1A. Cell Prolif. 2017 Oct;50(5):e12364. doi: 10.1111/cpr.12364. Epub 2017 Jul 24.

  PMID: 28737263 RESULT

• Chida K, Kanazawa H, Kinoshita H, Roy AM, Hakamada K, Takabe K. The role of lidocaine in cancer progression and patient survival. Pharmacol Ther. 2024 Jul;259:108654. doi: 10.1016/j.pharmthera.2024.108654. Epub 2024 May 1.

  PMID: 38701900 RESULT

• Manoleras AV, Sloan EK, Chang A. The sympathetic nervous system shapes the tumor microenvironment to impair chemotherapy response. Front Oncol. 2024 Sep 24;14:1460493. doi: 10.3389/fonc.2024.1460493. eCollection 2024.

  PMID: 39381049 RESULT

• Ramirez MF, Tran P, Cata JP. The effect of clinically therapeutic plasma concentrations of lidocaine on natural killer cell cytotoxicity. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):43-8. doi: 10.1097/AAP.0000000000000191.

  PMID: 25469757 RESULT

• Zhang H, Wang J, Li F. Modulation of natural killer cell exhaustion in the lungs: the key components from lung microenvironment and lung tumor microenvironment. Front Immunol. 2023 Nov 6;14:1286986. doi: 10.3389/fimmu.2023.1286986. eCollection 2023.

  PMID: 38022613 RESULT

• Piegeler T, Votta-Velis EG, Liu G, Place AT, Schwartz DE, Beck-Schimmer B, Minshall RD, Borgeat A. Antimetastatic potential of amide-linked local anesthetics: inhibition of lung adenocarcinoma cell migration and inflammatory Src signaling independent of sodium channel blockade. Anesthesiology. 2012 Sep;117(3):548-59. doi: 10.1097/ALN.0b013e3182661977.

  PMID: 22846676 RESULT

• Sullivan R, Alatise OI, Anderson BO, Audisio R, Autier P, Aggarwal A, Balch C, Brennan MF, Dare A, D'Cruz A, Eggermont AM, Fleming K, Gueye SM, Hagander L, Herrera CA, Holmer H, Ilbawi AM, Jarnheimer A, Ji JF, Kingham TP, Liberman J, Leather AJ, Meara JG, Mukhopadhyay S, Murthy SS, Omar S, Parham GP, Pramesh CS, Riviello R, Rodin D, Santini L, Shrikhande SV, Shrime M, Thomas R, Tsunoda AT, van de Velde C, Veronesi U, Vijaykumar DK, Watters D, Wang S, Wu YL, Zeiton M, Purushotham A. Global cancer surgery: delivering safe, affordable, and timely cancer surgery. Lancet Oncol. 2015 Sep;16(11):1193-224. doi: 10.1016/S1470-2045(15)00223-5.

  PMID: 26427363 RESULT

• Foo I, Macfarlane AJR, Srivastava D, Bhaskar A, Barker H, Knaggs R, Eipe N, Smith AF. The use of intravenous lidocaine for postoperative pain and recovery: international consensus statement on efficacy and safety. Anaesthesia. 2021 Feb;76(2):238-250. doi: 10.1111/anae.15270. Epub 2020 Nov 3.

  PMID: 33141959 RESULT

• Paterson H, Vadiveloo T, Innes K, Balfour A, Atter M, Stoddart A, Cotton S, Arnott R, Aucott L, Batham Z, Foo I, MacLennan G, Nimmo S, Speake D, Norrie J. Intravenous Lidocaine for Gut Function Recovery in Colonic Surgery: A Randomized Clinical Trial. JAMA. 2025 Jan 7;333(1):39-48. doi: 10.1001/jama.2024.23898.

  PMID: 39602290 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Recurrence

Interventions

Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Changshun Huang, MD

  First Affiliated Hospital of Ningbo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changshun Huang, MD

CONTACT

+8613957882779; fyyhuangchangshun@nbu.edu.cn

Yong Li

CONTACT

+8615168541165; yongli332603@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A random coding table is generated by statistical analysts, placed in a sealed and opaque envelope, and managed by an independent randomization specialist. The randomization specialist configures the medication according to the coding information, attaches the coding, and then provides it to the blinded anesthesiologist. Both patients, investigators and postoperative follow-up personnel are also blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Departmental director

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)