Effect of Perioperative Lidocaine or High-Dose Dexamethasone on Immune Response in Colon Cancer Surgery (PILDI Study)
Recruiting · NCT07432399 · Interventional (participants receive a specific treatment) · Lead sponsor: Institute of Oncology Ljubljana
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- Institute of Oncology Ljubljana - Ljubljana, Slovenia