RecruitingPhase 2NCT07432399

Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)

Effect of Perioperative Intravenous Infusion of Lidocaine or High Dose Dexamethasone on the Immune Response in Patients Undergoing Surgery for Colon Cancer - The PILDI Study

Sponsor

Institute of Oncology Ljubljana

Enrollment

100 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

Summary

This study is a prospective, randomized, double-blind, phase II interventional clinical trial evaluating the effect of perioperative intravenous lidocaine infusion compared with high-dose dexamethasone on postoperative immune response and clinical outcomes in patients undergoing surgery for colon cancer. Patients with colon cancer often experience postoperative inflammatory and immune changes that may influence recovery and complications. The aim of this study is to assess whether perioperative lidocaine infusion may improve postoperative immune function and clinical recovery compared with standard perioperative anti-inflammatory treatment. Participants will be randomly assigned to receive either intravenous lidocaine infusion or high-dose dexamethasone during the perioperative period. Immune response markers and postoperative clinical outcomes will be evaluated. The results of this trial may contribute to improved perioperative management and recovery strategies for patients undergoing surgery for colon cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Adult patients aged 18 years or older
Histologically confirmed colon cancer
Scheduled for elective surgical resection of colon cancer
Eligible for perioperative treatment with study medication (lidocaine, dexamethasone, or placebo) according to the protocol
Ability to understand the study procedures and provide written informed consent

Exclusion Criteria8

Known allergy or hypersensitivity to lidocaine, dexamethasone, or any excipients
Severe hepatic impairment
Severe renal impairment
Severe cardiac conduction disorders or clinically significant arrhythmias
Pregnancy or breastfeeding
Severe uncontrolled comorbidities that could interfere with study participation
Participation in another interventional clinical trial that could influence study outcomes
Any other condition which, in the opinion of the investigator, makes the patient unsuitable for participation

Interventions

DRUGLidocaine

Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.

DRUGDexamethasone

High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.

DRUGPlacebo

Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.