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A study evaluating the effects of intravenous lidocaine on pain control and recovery after colon cancer surgery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with colon cancer who are scheduled for surgery. The research examines how giving lidocaine (a pain-relieving medication) through an intravenous infusion during and after surgery affects recovery and the body's immune response. Some patients will receive lidocaine, while others will receive a placebo through the same type of infusion.

The main purpose of this research is to determine if patients who receive lidocaine during their colon cancer surgery need less pain medication (specifically opioid medications) in the first 24 hours after their operation. The study will also look at how quickly patients regain normal bowel function after surgery.

During the study, patients will receive either lidocaine or a sodium chloride solution (standard salt water) through an intravenous line. The treatment will be given during the surgical procedure and continue for a short time afterward. The amount of pain medication needed and the time until normal bowel function returns will be monitored after the surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial participation

    You will undergo evaluation for colon cancer surgery using laparoscopic method

    Your eligibility will be confirmed based on age (18-80 years) and general health condition

    The procedure will include creating a connection (anastomosis) between healthy parts of the colon

  2. Step 2

    Surgery day preparation

    You will be randomly assigned to receive either lidocaine or a placebo through an intravenous line

    The medical team will prepare for your laparoscopic colon surgery

    The intravenous medication will begin before the surgical procedure

  3. Step 3

    During surgery

    The surgical team will perform the laparoscopic colon cancer removal

    You will continue receiving the assigned intravenous medication (lidocaine or placebo)

    The procedure includes removing the affected part of the colon and connecting the healthy ends

  4. Step 4

    First 24 hours after surgery

    Your pain levels will be monitored and managed with pain medication as needed

    The medical team will track the amount of pain medication you require

    Your comfort level will be regularly assessed

  5. Step 5

    Post-surgery monitoring

    The medical team will monitor your recovery progress

    Your bowel function will be tracked to record when normal movement returns

    Your overall response to the surgery and pain management will be documented

Who can join the trial?

6 criteria

  • Patient must have colon cancer that can be treated with planned minimally invasive surgery (laparoscopic procedure) where the affected part of the colon will be removed and the remaining ends reconnected (anastomosis)
  • Patient must be between 18 and 80 years old
  • Patient must have low to medium risk for anesthesia complications (classified as ASA score up to 3, which is a medical scale used to assess a patient's physical health before surgery)
  • Patient must be able to understand the study procedures and willingly sign an informed consent form
  • Both men and women can participate in the study
  • Patient must not belong to any vulnerable population groups (such as prisoners, mentally disabled individuals, or others who may be unable to give fully informed consent)

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Known allergy or hypersensitivity to lidocaine or similar local anesthetics
  • Severe heart conditions or abnormal heart rhythm
  • Severe liver disease that affects medication processing
  • Pregnancy or breastfeeding
  • Current use of medications that could interact with lidocaine
  • History of chronic pain requiring regular opioid use
  • Mental conditions that could affect pain assessment
  • Inability to understand or follow study instructions
  • Emergency or unplanned colorectal surgery
  • Participation in another clinical trial within the past 30 days
  • Any condition that, in the opinion of the study doctor, makes participation unsafe
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Investigated drugs

Lidocaine is a local anesthetic medication given through an intravenous (IV) infusion during and after surgery. It helps reduce pain by blocking nerve signals in the body. In this study, it is being investigated for its ability to reduce the need for opioid pain medications after colon cancer surgery and its potential effects on the body's immune response. Lidocaine is commonly used in medical procedures and has been safely used for many years as a pain-relieving medication.

What is already known about the treatment

Lidocaine - An injectable local anesthetic medication administered through intravenous infusion during and after surgical procedures. It belongs to the amino amide group of local anesthetics and works by blocking sodium channels in nerve cells, preventing the transmission of pain signals. Lidocaine is widely used in modern medicine for pain management during surgical procedures and postoperative care, particularly in colorectal cancer surgeries where it can help reduce opioid consumption and improve recovery outcomes. The medication has demonstrated significant effectiveness in managing post-surgical pain while potentially modulating the immune response, making it valuable in perioperative care protocols.

Investigated diseases

Colon cancer - A disease that begins in the large intestine (colon), where healthy cells in the colon start to grow uncontrollably and form tumors. The condition typically develops from small, benign clumps of cells called polyps that form on the inner lining of the colon. Over time, some of these polyps can become cancerous. The disease usually develops slowly, often taking several years to progress from early to advanced stages. As the condition advances, cancer cells can grow through the colon wall and spread to nearby structures and lymph nodes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521808-22-01Protocol codeORI2025-16Estimated enrolment100 patientsSponsorInstitute Of Oncology Ljubljana

sourced from the EU Clinical Trials Register and site verification

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