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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colon Cancer; Perioperative Immune Response
• Intervention / Treatment: Drug: Lidocaine; Drug: Dexamethasone; Drug: Placebo

Detailed Description

This study is a prospective, randomized, double-blind, controlled phase II interventional clinical trial conducted at the Institute of Oncology Ljubljana. The trial investigates the effects of two perioperative pharmacological interventions-intravenous lidocaine infusion and high-dose dexamethasone-on postoperative immune response and clinical outcomes in patients undergoing surgical treatment for colon cancer.

Patients undergoing major oncologic surgery may develop significant perioperative immune suppression and inflammatory responses, which can influence postoperative recovery, complication rates, and overall outcomes. Lidocaine is known to have potential anti-inflammatory and immunomodulatory effects, while dexamethasone is widely used perioperatively for its anti-inflammatory properties. However, comparative evidence regarding their impact on postoperative immune response in colorectal cancer surgery is limited.

Eligible participants are adult patients with histologically confirmed colon cancer who are scheduled for surgical resection. After providing written informed consent, participants will be randomized in a double-blind manner to one of two study groups:

Perioperative intravenous lidocaine infusion group

High-dose perioperative dexamethasone group

Both interventions are administered according to the study protocol during the perioperative period. Randomization and masking ensure that participants, investigators, and clinical staff remain blinded to treatment allocation.

The primary objective of the study is to evaluate differences in postoperative immune response between the two intervention arms, assessed through laboratory immune and inflammatory markers. Secondary objectives include evaluation of postoperative clinical outcomes, such as postoperative recovery parameters and complications.

Participants are followed during the perioperative period and after surgery, and study assessments are performed according to the predefined schedule. This study will provide evidence regarding whether perioperative lidocaine infusion may offer beneficial immunological or clinical effects compared with high-dose dexamethasone in patients undergoing surgery for colon cancer. The results may support improved perioperative supportive care strategies and optimization of postoperative recovery in oncologic surgical patients.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nikola Bešić, MD, PhD; Phone Number: 015879935; Email: NBesic@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Klavdija Korošec; Phone Number: 031 6300 65; Email: kkorosec@onko-i.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Lidocaine; Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.
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.	Drug: Dexamethasone; High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.
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.	Drug: Placebo; Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Cytokine Concentrations (IL-6, IL-8, IL-10, TNF-alpha)	Perioperative immune response is assessed by measuring serum inflammatory cytokine concentrations (IL-6, IL-8, IL-10, and TNF-alpha). Cytokine concentrations are compared between the lidocaine infusion group, the high-dose dexamethasone group, and the placebo group to evaluate differences in inflammatory response following colon cancer surgery.	Baseline (before anesthesia induction), 2 hours after surgery, postoperative day 1, and postoperative day 2.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption Within 24 Hours After Surgery	Total postoperative opioid consumption is assessed as the cumulative dose of opioid analgesics administered within the first 24 hours after surgery and compared between study groups.	First 24 hours after surgery.
Postoperative Pain Intensity Measured by the Visual Analogue Scale	Postoperative pain intensity is assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores are compared between study groups.	2 hours after surgery and postoperative days 1 and 2.
Time to First Postoperative Bowel Movement	Time to first postoperative bowel movement is recorded as an indicator of gastrointestinal recovery and compared between study groups.	From end of surgery until first postoperative bowel movement (up to postoperative day 7).
Incidence of Postoperative Complications	Incidence of postoperative complications is assessed and compared between study groups, including surgical complications and adverse events potentially related to study medications.	From surgery through postoperative day 30.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Length of hospital stay is assessed as the number of days from surgery until hospital discharge and compared between study groups.	From surgery until hospital discharge (up to postoperative day 30).

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 18, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Lidocaine; Intravenous Lidocaine; PILDI
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Colonic Neoplasms; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Pregnadienetriols; Dexamethasone; Lidocaine
• Other Study ID Numbers: ORI2025-16; 2025-521808-22-00 (Other Identifier: Clinical Research Unit, Institute of Oncology Ljubljana)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No