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

Sponsor
Institute of Oncology Ljubljana
Study ID
NCT07432399
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine — DRUG
    Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.
  • Dexamethasone — DRUG
    High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
  • Placebo — DRUG
    Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.

Study Details

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.

Key Dates

First listed
Feb 25, 2026
Start date
Sep 1, 2025
Status verified
Feb 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha) [ Time Frame: Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2. ]

Central Contacts

Find similar trials

Nationwide
Colorectal cancer trialsOncology trialsGI oncology trials

Related Studies