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Study on the Effect of Continuous Intravenous Lidocaine and Sodium Chloride on Comfort in Postoperative Critical Care Patients

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 clinical trial is focused on patients who are in postoperative critical care, which means they are receiving intensive medical attention after undergoing major surgery. The study is investigating the effects of a medication called lidocaine hydrochloride monohydrate, which is commonly used as a local anesthetic to numb tissue in a specific area. In this trial, it is being administered continuously through an intravenous (IV) line to see if it can help improve the comfort of patients during their stay in the intensive care unit.

The purpose of the study is to determine whether the continuous administration of lidocaine during the first 48 hours after surgery can enhance patients' comfort levels. Patients will receive either the lidocaine treatment or a placebo for comparison. The study will monitor patients' comfort using a questionnaire that assesses various aspects of discomfort, such as noise, thirst, pain, and anxiety, among others. The trial will also track other factors like the use of pain medication, the duration of mechanical ventilation, and the length of stay in critical care.

Participants in the study will be closely observed for any side effects related to the use of lidocaine. The trial aims to provide valuable insights into whether this treatment can make a significant difference in the recovery experience of patients in critical care after major surgeries. The study is expected to continue until 2027, with recruitment starting in 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, informed consent must be obtained and signed. This can be done by you, a close relative, or a legal representative. If none of these options are available, an emergency procedure will be followed.

  2. Step 2

    Admission to critical care

    You will be admitted to critical care immediately after your surgery. This could be a planned or emergency admission, depending on the type of surgery you have undergone, such as exploratory laparotomy, cardiac surgery, or major orthopedic surgery.

  3. Step 3

    Medication administration

    You will receive a continuous intravenous administration of lidocaine hydrochloride monohydrate and sodium chloride for the first 48 hours after your surgery. This is to help improve your comfort during your stay in the intensive care unit.

  4. Step 4

    Monitoring and assessment

    Your comfort and overall condition will be monitored throughout your stay. An assessment using the IPREA questionnaire, which evaluates discomfort in critical care patients, will be conducted within 24 hours of your discharge from critical care or within 24 hours of the 30th day of hospitalization if you remain in critical care.

  5. Step 5

    Additional evaluations

    Additional evaluations will be conducted to assess various factors such as noise, thirst, pain, medical devices, sleepiness, breathing difficulties, anxiety, and depression. These evaluations will occur within 24 hours before your discharge from critical care or before the 30th day of hospitalization.

  6. Step 6

    End of trial participation

    Your participation in the trial will conclude after the assessments and evaluations are completed. The trial aims to determine the effectiveness of the medication in improving comfort during your critical care stay.

Who can join the trial?

5 criteria

  • The patient must be an adult.
  • The patient must be admitted to critical care immediately after surgery. This can be a planned or emergency admission, such as after major surgeries like exploratory abdominal surgery, heart surgery, complex bone surgeries involving multiple injuries, or vascular surgeries with high risk of complications like open aortic surgery.
  • The patient is expected to stay in critical care for at least 48 hours.
  • The patient must be a member of a social security scheme.
  • Informed consent must be obtained and signed by the patient, or by a close relative or legal representative. If this is not possible, an emergency procedure must be followed.

Who cannot join the trial?

5 criteria

  • Patients who are not in need of postoperative critical care cannot participate. This means if you are not recovering from surgery in a critical care setting, you are not eligible.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of patients.
  • Patients who are not male or female cannot participate. The study is open to both men and women.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like the elderly or those with certain health conditions.
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Investigated drugs

Lidocaine is a medication used in this clinical trial to help reduce discomfort for patients who have just had surgery and are staying in critical care units. It is given continuously through an intravenous line, which means it is delivered directly into the bloodstream over a period of time. The goal of using Lidocaine in this way is to see if it can make patients feel more comfortable during the first 48 hours after their surgery while they are being closely monitored in the hospital.

What is already known about the treatment

Lidocaine – Lidocaine is administered continuously through an intravenous (IV) drip, which means it is delivered directly into the bloodstream via a needle inserted into a vein. Currently, Lidocaine is being studied for its potential benefits in improving comfort for patients in critical care after surgery. It is primarily used to help manage pain and discomfort in these settings. At the molecular level, Lidocaine works by blocking sodium channels in nerve cells, which helps to reduce the sensation of pain. It is classified as a local anesthetic and antiarrhythmic medication.

Investigated diseases

Postoperative critical care – This condition involves the management and support of patients who have undergone surgery and require intensive monitoring and care. It typically occurs in an intensive care unit (ICU) where patients are closely observed for any complications that may arise after surgery. The progression involves monitoring vital signs, managing pain, and ensuring that the patient is stable. Patients may experience discomfort due to medical devices, noise, or other factors. The condition may also involve the use of mechanical ventilation and sedation. The goal is to stabilize the patient and facilitate recovery from surgery.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517749-15-00Protocol code35RC22_8943_LIDOCRITEstimated enrolment246 patientsSponsorCentre Hospitalier Universitaire De Rennes

sourced from the EU Clinical Trials Register and site verification

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