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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-02-05
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
Interventions
- DRUG
-
Lidocaine
intravenous infusion of lidocaine
- DRUG
-
saline solution intravenous infusion
Sponsors & Collaborators
-
Institute of Oncology Ljubljana
lead OTHER
Principal Investigators
-
Nikola Bešić, MD · Institute of Oncology Ljubljana
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-03
- Primary Completion
- 2027-07-01
- Completion
- 2028-07-01
Countries
- Slovenia
Study Locations
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