Effect of Intravenous Infusion of Lidocaine on Patients Undergoing Radical Resection of Colorectal Tumors

Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Surgical resection is the main treatment option for colorectal cancer patients. Surgery may enhance or accelerate tumor recurrence and metastasis. Multiple factors in the tumor microenvironment play important roles in tumor recurrence and metastasis, and modulating the tumor microenvironment can inhibit disease progression. Lidocaine has been found to inhibit tumor growth in animal experiments.

Study Overview

• Status: Completed
• Conditions: Colorectal Tumors; Lidocaine
• Intervention / Treatment: Drug: Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation

Detailed Description

Lidocaine was applied in the operation of colorectal tumor patients, and the effect on the postoperative microenvironment and micrometastasis of the patients was observed by detecting the stress, immunity, vascular tumor regeneration, inflammation, etc. of the patients.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haihang Miao

Study Locations

• China
  • Jiangsu
    • Nantong, Jiangsu, China, 226001
      • Affiliated Hospital of Nantong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• colorectal tumor patients

Exclusion Criteria:

• Weight <45kg and >100kg
• Sensitivity or hypersensitivity to lidocaine
• Second or third degree heart block
• Severe heart failure (ejection fraction < 20%)
• History of active rhythm disorder
• Acute severe liver and kidney injury
• History of uncontrolled seizures
• History of acute porphyria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine is used in radical resection of colorectal tumors.; Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation	Drug: Administer 1.5 mg/kg intravenously to the patient before induction of anesthesia, and continue to infuse 1.5 mg/kg/h during the operation until the end of the operation; Administer 1.5 mg/kg lidocaine; Other Names: same volume of saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the concentration of tumor micrometastasis markers were determined by ELISA	the concentration of tumor micrometastasis markers such as CK20 was determined by ELISA	3 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the concentration of stress hormones were determined by ELISA	the concentration of EPI and NE were determined by ELISA	3 days after surgery
the concentration of inflammatory factor were determined by ELISA	the concentration of IL-6,IL-8,TNF-α were determined by ELISA	3 days after surgery
the concentration of angiogenesis factors were determined by ELISA	the concentration of VEGF was determined by ELISA	3 days after surgery
the concentration of immune indexes were determined by ELISA	the concentration of B lymphocytes, T lymphocytes, NK cells, macrophages were determined by ELISA	3 days after surgery

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Nantong University
• Investigators: Principal Investigator: hongsheng chen, Chair

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: lidocaine; stress; inflammation; immunity; micrometastasis; Radical resection of colorectal tumor; vascular tumor regeneration
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: MA2021008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No