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Study on Lidocaine and Magnesium Sulfate for Patients Undergoing Lung Surgery with Video-Assisted Thoracic Surgery (VATS)

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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 undergoing lung resection surgery using a method called Video-Assisted Thoracic Surgery (VATS). The study is investigating the use of two medications, lidocaine and magnesium sulfate, to see if they can help reduce the need for pain medication, specifically morphine, in the first 24 hours after surgery. Lidocaine is commonly used as a local anesthetic to numb tissues in a specific area, while magnesium sulfate is often used to treat low magnesium levels and other conditions.

The purpose of the study is to determine if administering these medications through an intravenous infusion during surgery can decrease the amount of morphine needed afterward. Patients will receive either the study medications or a placebo during their surgery. The trial will monitor various outcomes, including the amount of morphine used, pain levels, and any complications that may arise after the surgery.

Participants will be observed for their recovery quality, including their lung capacity and overall health, to assess the effectiveness and safety of the treatment. The study aims to provide valuable insights into improving pain management and recovery for patients undergoing lung surgery with VATS.

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 trial

    Participation begins after meeting the criteria: being 18 years or older, undergoing lung tumor resection surgery using video-assisted thoracoscopy, and providing consent.

    The investigator assesses the ability to comply with trial requirements.

  2. Step 2

    Pre-surgery preparation

    Preparation for lung resection surgery using Video-Assisted Thoracic Surgery (VATS) is conducted.

    No specific medications are administered at this stage.

  3. Step 3

    Intraoperative medication administration

    During surgery, lidocaine hydrochloride and magnesium sulfate heptahydrate are administered intravenously.

    These medications are given as a solution for injection or infusion to potentially reduce morphine consumption post-surgery.

  4. Step 4

    Postoperative monitoring

    Monitoring of morphine consumption occurs in the first 24 hours after surgery.

    Pain intensity, both at rest and during deep breathing, is assessed.

  5. Step 5

    Follow-up assessments

    Further evaluations include chronic postoperative pain, neuropathic pain, and any adverse events.

    Additional assessments cover ICU and hospital stay duration, pulmonary and non-pulmonary complications, and overall recovery quality.

  6. Step 6

    Long-term evaluations

    Long-term follow-up includes checking for lung cancer recurrences, quality of life, and any cognitive dysfunction post-surgery.

    Other evaluations involve lung capacity, oxygenation, and potential hospital readmissions.

Who can join the trial?

4 criteria

  • Patients must be having surgery to remove a lung tumor using a method called video-assisted thoracoscopy, which is a type of surgery done with the help of a camera.
  • The patient must be 18 years of age or older.
  • The patient, or their representative, must have given consent to participate in the study, meaning they agree to be part of the research.
  • The patient must be able, in the opinion of the investigator, to follow all the requirements of the clinical trial, which means they can do everything needed for the study.

Who cannot join the trial?

3 criteria

  • Patients who are not undergoing lung surgery using a method called Video-Assisted Thoracic Surgery (VATS). This is a type of surgery where doctors use a small camera and instruments to operate on the lungs through small cuts in the chest.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population, which means groups of people who might need special protection or care.
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Investigated drugs

  • Lidocaine

    is a medication used to numb tissue in a specific area. In this trial, it is administered intravenously during lung resection surgery to help reduce pain and potentially decrease the need for morphine after the operation.

  • Magnesium Sulfate

    is a mineral that can be used as a medication to help relax muscles and nerves. In this study, it is given intravenously during lung surgery to see if it can help reduce pain and lower the amount of morphine needed after the surgery.

What is already known about the treatment

  • Lidocaine

    Lidocaine is administered intravenously and is commonly used as a local anesthetic and antiarrhythmic agent. It is currently well-established in medical practice and literature for its anesthetic properties. In the context of lung resection surgery using Video-Assisted Thoracic Surgery (VATS), it is being studied for its potential to reduce morphine consumption postoperatively. Lidocaine works by blocking sodium channels at the molecular level, which inhibits nerve impulse conduction. It is classified pharmacologically as a local anesthetic.

  • Magnesium Sulfate

    Magnesium sulfate is administered intravenously and is used in various medical conditions, including as a treatment for eclampsia and as a laxative. In the context of lung resection surgery using VATS, it is being investigated for its ability to reduce the need for morphine in the postoperative period. Magnesium sulfate acts by modulating calcium influx and influencing neurotransmitter release, which can have a calming effect on nerve activity. It is classified as a mineral supplement and anticonvulsant.

Investigated diseases

  • Atrial Fibrillation

    Atrial fibrillation is a common heart rhythm disorder where the heart's upper chambers (atria) beat irregularly and often rapidly. This irregular rhythm can lead to poor blood flow and may cause symptoms like palpitations, fatigue, and shortness of breath. The condition can vary in duration, with episodes lasting from minutes to hours, or it can be persistent. Over time, atrial fibrillation can lead to complications such as blood clots or heart failure if not managed properly.

  • Acute Kidney Injury

    Acute kidney injury is a sudden episode of kidney failure or damage that happens within a few hours or days. It causes waste products to build up in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. This condition can occur due to various factors, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. It is often reversible with prompt treatment, but severe cases can lead to long-term kidney damage.

  • Postoperative Cognitive Dysfunction

    Postoperative cognitive dysfunction is a decline in cognitive function that can occur after surgery, particularly in older adults. It may affect memory, concentration, and the ability to process information. The condition can be temporary or persist for a longer period, impacting the patient's quality of life. Factors contributing to this dysfunction include the type of surgery, anesthesia, and the patient's pre-existing health conditions.

  • Chronic Postoperative Pain

    Chronic postoperative pain is pain that persists for more than three months after surgery. It can result from nerve damage during the procedure or ongoing inflammation. This type of pain can significantly affect a patient's daily activities and emotional well-being. Managing chronic postoperative pain often requires a multidisciplinary approach to address both physical and psychological aspects.

  • Neuropathic Pain

    Neuropathic pain is a type of pain caused by damage or dysfunction in the nervous system. It is often described as a burning, shooting, or stabbing sensation and can occur in various parts of the body. This pain can be persistent and challenging to manage, as it does not respond well to standard pain medications. Neuropathic pain can result from conditions such as diabetes, shingles, or nerve injuries.

  • Myocardial Damage in Non-Cardiac Surgery

    Myocardial damage in non-cardiac surgery refers to injury to the heart muscle that occurs during or after surgical procedures not involving the heart. This damage can be due to reduced blood flow to the heart, stress on the heart during surgery, or other factors. It may lead to symptoms such as chest pain or shortness of breath and can increase the risk of further heart complications. Monitoring and managing heart health is crucial in patients undergoing non-cardiac surgery to prevent such damage.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509503-33-00Estimated enrolment128 patientsSponsorClinica Universidad De Navarra

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