Perioperative lidocaine vs high-dose dexamethasone for colon cancer surgery
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 trial tests whether giving intravenous lidocaine around the time of surgery instead of high‑dose dexamethasone helps preserve immune function and improve recovery in adults having colon cancer surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Oncology Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT07432399 on ClinicalTrials.gov |
What this trial studies
This randomized, double‑blind phase II trial at the Institute of Oncology Ljubljana enrolls adults with histologically confirmed colon cancer scheduled for elective resection. Participants are randomly assigned to receive either a perioperative intravenous lidocaine infusion or high‑dose perioperative dexamethasone, with participants and clinical staff blinded to assignment. The study measures postoperative immune response markers and clinical outcomes such as recovery and complication rates. Findings will compare the immunomodulatory and clinical effects of the two perioperative approaches.
Who should consider this trial
Good fit: Ideal candidates are adults with confirmed colon cancer who are scheduled for elective surgical resection, are eligible for perioperative lidocaine or dexamethasone, and can give informed consent.
Not a fit: Patients with severe liver or kidney impairment, significant cardiac conduction disorders, known allergy to lidocaine or dexamethasone, pregnant or breastfeeding patients, or those judged unsuitable by investigators are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could identify a simple perioperative medication strategy that preserves immune function, speeds recovery, and reduces complications after colon cancer surgery.
How similar studies have performed: Prior work has reported anti-inflammatory and immunomodulatory effects of perioperative lidocaine and routine perioperative benefits of dexamethasone, but direct randomized comparisons of their effects on immune markers in colorectal cancer surgery remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ljubljana
- Institute of Oncology Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Nikola Bešić, MD, PhD
- Email: NBesic@onko-i.si
- Phone: 015879935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.