drugset / Trial / NCT07432399

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

NCT07432399

Phase 2 Recruiting 100 enrolled Institute of Oncology Ljubljana
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-09-01
Primary completion
2027-05-01
Completion
2027-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule Intravenous
Subject Lidocaine Other / unclassified Intravenous

Indications