Actively Recruiting
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
Led by Institute of Oncology Ljubljana · Updated on 2026-02-05
100
Participants Needed
2
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have colon cancer at any stage and scheduled for elective laparoscopic colon resection and colonic anastomosis
- Are between 18 and 80 years old
- Are classified as low to moderate anesthesia risk (ASA up to 3)
- Can understand the study and provide informed consent
You will not qualify if you...
- Receiving neoadjuvant chemotherapy
- Are pregnant or breastfeeding
- Have a known allergy to lidocaine
- Have cardiac rhythm problems such as bradycardia under 45 beats/min, complete heart block, or use of group III antiarrhythmics
- Have had cardiac arrest
- Have porphyria
- Have myasthenia gravis
- Have severe liver problems such as cirrhosis, ascites, bleeding disorders, jaundice, or encephalopathy
- Have kidney disease requiring hemodialysis or creatinine clearance under 30 mL/min
- Have epilepsy
- Have an active infection
- Have viral or systemic fungal disease
- Have uncontrolled psychosis
- Have ulcerative stomach or duodenal disease
- Are on chronic corticosteroid therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Not Yet Recruiting
2
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
Research Team
E
Eva Černe, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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