Clinical trial · Interventional
Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk
Lidocaine Infusion Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk: a Multicenter Randomized Controlled Study
NCT07347977CI-TRIAL-00101081LidCRMnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Recurrence | — | UNRESOLVED | — |
| Survival Analysis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lidocaine (drug) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- lidocine infusion group
- description
- 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.
- interventionNames
- Drug: Lidocaine (drug)
- type
- PLACEBO_COMPARATOR
- label
- normal saline group
- description
- The normal saline is administered at the volume calculated based on the equivalent volume of lidocaine dose according to body weight
- interventionNames
- Drug: Lidocaine (drug)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (12)
- RESULTHiller 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
- RESULTBen-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
- RESULTWall 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
- RESULTZhang 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
- RESULTChida 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
- RESULTManoleras 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
- RESULTRamirez 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
- 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.