Effect of Perioperative Intravenous Infusion of Lidocaine on the Postoperative Course and the Immune Response in Patients Undergoing Surgery for Colon Cancer - the PILDI Study

NCT06923787 | Recruiting Phase 2

• 2 other identifiers: ORI2025-0162025-521808-22-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

There are very few data in the literature on changes in inflammatory markers when lidocaine is administered perioperatively in patients with colorectal cancer. In patients undergoing surgery for colon cancer, the aim is to conduct a double-blind placebo-controlled study to determine differences in levels of pro-inflammatory markers, postoperative pain and opioid analgesic consumption in the first two days after surgery, and the time to first postoperative bowel movement. Groups of patients receiving perioperative lidocaine infusion, high dose dexamethasone or placebo will be compared.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Difference in opioid use in 24 hours after surgery between arms

  Patients who receive a perioperative infusion of lidocaine will have lower need for opioid consumption oppose to placebo arm

  24 hours after surgery

Secondary Outcomes (1)

• Time to bowel movement after surgery

  observation within 30 days after surgery

Study Arms (2)

Lidokaine arm

ACTIVE COMPARATOR

Patients who will receive intravenous lidocaine.

Drug: Lidocaine

Placebo arm

PLACEBO COMPARATOR

Patients who will receive placebo.

Drug: Placebo

Interventions

Lidocaine DRUG

intravenous infusion of lidocaine

Lidokaine arm

Placebo DRUG

saline solution intravenous infusion

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• colon cancer of any stage of the disease for which elective laparoscopic colon resection and colonic anastomosis will be performed,
• age of patients between 18 and 80 years,
• low to moderate risk of anesthesia (ASA up to and including 3),
• ability to understand the study and to sign an informed consent to participate in the study

You may not qualify if:

• patients receiving neoadjuvant chemotherapy,
• pregnancy or breastfeeding,
• known allergy to lidocaine
• cardiac rhythm disturbances (bradycardia \< 45 beats/min, complete heart block, use of group III antiarrhythmics),
• status post cardiac arrest,
• porphyria,
• myasthenia gravis,
• severe hepatic impairment (cirrhosis, ascites, bleeding disorders, jaundice, encephalopathy),
• renal disease (hamodialysis, creatinine clearance \<30 mL/min),
• epilepsy,
• active infection,
• presence of viral or systemic fungal disease,
• uncontrolled psychotic state,
• ulcerative gastric or duodenal disease,
• chronic corticosteroid therapy.

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (2)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

NOT YET RECRUITING

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nikola Bešić, MD

  Institute of Oncology Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Černe, MD

CONTACT

0038615879844; ecerne@onko-i.si

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind randomized trial

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: February 3, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2)