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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Nikola Bešić, MD, PhD
NBesic@onko-i.si
015879935
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 100
Treatments
Experimental: Lidocaine Infusion Group
Participants receive perioperative intravenous lidocaine infusion in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
Experimental: High-Dose Dexamethasone Group
Participants receive perioperative high-dose intravenous dexamethasone in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
Placebo_comparator: Placebo Group
Participants receive perioperative intravenous placebo in addition to standard perioperative care during surgery for colon cancer. Outcomes include immune response parameters and postoperative recovery measures.
Related Therapeutic Areas
Sponsors
Leads: Institute of Oncology Ljubljana

This content was sourced from clinicaltrials.gov