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

NCT07432399 | Recruiting Phase 2

• 2 other identifiers: ORI2025-162025-521808-22-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Colorectal Cancer; Perioperative Immune Response

Keywords

PILDI; Lidocaine; Intravenous Lidocaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Opioid Consumption Within 24 Hours After Surgery

  First 24 hours after surgery.

• Postoperative Pain Intensity Measured by the Visual Analogue Scale

  2 hours after surgery and postoperative days 1 and 2.

• Time to First Postoperative Bowel Movement

  From end of surgery until first postoperative bowel movement (up to postoperative day 7).

• Incidence of Postoperative Complications

  From surgery through postoperative day 30.

Other Outcomes (1)

• Length of Hospital Stay

  From surgery until hospital discharge (up to postoperative day 30).

Study Arms (3)

Lidocaine Infusion Group

EXPERIMENTAL

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

High-Dose Dexamethasone Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Lidocaine DRUG

Perioperative intravenous lidocaine infusion administered during colorectal cancer surgery according to the study protocol, in addition to standard perioperative care.

Lidocaine Infusion Group

Dexamethasone DRUG

High-dose perioperative intravenous dexamethasone administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.

High-Dose Dexamethasone Group

Placebo DRUG

Perioperative intravenous placebo administered according to the study protocol, in addition to standard perioperative care during colorectal cancer surgery.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Interventions

Lidocaine; Dexamethasone

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Nikola Bešić, MD, PhD

CONTACT

015879935; NBesic@onko-i.si

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design: participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. Study medication is prepared and labeled in an identical manner to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel-group randomized controlled trial with three study arms comparing perioperative intravenous lidocaine infusion, high-dose dexamethasone, and placebo in patients undergoing surgery for colon cancer.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 25, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)