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

ConditionColon Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Oncology Ljubljana

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Lidocaine

    Drug

    intravenous infusion of lidocaine

  • Placebo

    Drug

    saline solution intravenous infusion

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Lidokaine armActive comparator 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours after surgery

Secondary outcomes

1

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.

Time frame
observation within 30 days after surgery

Other outcomes

Sponsors and contacts

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