drugset / Trial / NCT07347977
Lidocaine Decreases Postoperative Lung Cancer Reoccurance and Metatasis Risk
Not yet recruiting
1400 enrolled
First Affiliated Hospital of Ningbo University
Ningbo Medical Center Lihuili Hospital · collabSecond Affiliated Hospital of Wenzhou Medical University · collabTaizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University · collab
RandomizedParallel-groupTriple-blindPrevention
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
Timeline
- Start
- 2026-01-01
- Primary completion
- 2029-09-30
- Completion
- 2029-12-30
Publications
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lidocaine | Other / unclassified | 1 mg/kg | Intravenous |
| Subject | Lidocaine | Other / unclassified | 1.5 mg/kg | Intravenous |