About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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),
Trial design
Parallel
Treatments tested in this trial
Lidocaine
Drugintravenous infusion of lidocaine
Placebo
Drugsaline solution intravenous infusion
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Time to bowel movement after surgery
Patients receiving a perioperative infusion of lidocaine will have a shorter time to first postoperative bowel movement than patients receiving placebo.
Sponsors and contacts
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