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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Slovenia
Institute of Oncology Ljubljana
NOT_YET_RECRUITING
Ljubljana
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Eva Černe, MD
ecerne@onko-i.si
0038615879844
Time Frame
Start Date: 2026-02-03
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Lidokaine arm
Patients who will receive intravenous lidocaine.
Placebo_comparator: Placebo arm
Patients who will receive placebo.
Related Therapeutic Areas
Sponsors
Leads: Institute of Oncology Ljubljana

This content was sourced from clinicaltrials.gov