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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

Study acronym: PILDI
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 3 to Phase 2 Trial status: Not Yet Recruiting to Recruiting · Start date changed from estimate of Nov 1, 2025 to Feb 3, 2026 · Primary endpoints: 4 to 1 · 10 morev2 Show 13 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 1, 2025 to Feb 3, 2026
    • Primary endpoints: 4 to 1
    • Enrollment target: 90 to 100
    • Study sites: 1 to 2
    • Primary completion date: May 1, 2027 to Jul 1, 2027
    • Completion date: May 1, 2028 to Jul 1, 2028
    • Interventions: Dexamethasone (Drug), Lidocaine (Drug), Placebo (Drug) to Lidocaine (Drug), Placebo (Drug)
    • Secondary endpoints: 6 to 1
    • Study description shortened, about 42 words
    • Study title expanded, about 14 words
    • Study arms: 3 to 2
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06923787
Lead Sponsor Institute of Oncology Ljubljana
Conditions Colon Cancer
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov