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

Sponsor
Institute of Oncology Ljubljana
Study ID
NCT06923787
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lidocaine — DRUG
    intravenous infusion of lidocaine
  • Placebo — DRUG
    saline solution intravenous infusion

Study Details

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.

Key Dates

First listed
Apr 11, 2025
Start date
Feb 3, 2026
Status verified
Jan 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Lidokaine arm
    Patients who will receive intravenous lidocaine.
  • Placebo Comparator: Placebo arm
    Patients who will receive placebo.

Primary Outcome Measure

Difference in opioid use in 24 hours after surgery between arms [ Time Frame: 24 hours after surgery ]

Central Contacts

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Colorectal cancer trialsOncology trialsGI oncology trials

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