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Evaluating intravenous lidocaine with intrathecal morphine for pain control in patients undergoing major abdominal surgery through laparotomy

Registered 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 pain management during major gastrointestinal surgery or abdominal surgery performed through laparotomy (a large surgical cut in the abdomen). The research examines the effectiveness of combining two pain relief methods: intravenous lidocaine (a numbing medication given through a vein) and intrathecal morphine (pain medication injected into the spinal fluid).

The main purpose is to determine if adding intravenous lidocaine to spinal morphine works better than using a placebo with spinal morphine for reducing the need for additional pain medication after surgery. The study compares two groups of patients - one receiving lidocaine and the other receiving placebo, along with spinal morphine.

During the study, patients undergo their planned abdominal surgery and receive either lidocaine or placebo through an intravenous line. The medication or placebo is given during and after the operation. Both groups receive spinal morphine as part of their pain management plan. The amount of additional pain medication needed and any side effects are monitored for several days after 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 procedure preparation

    You will undergo a major digestive or abdominal surgery through a surgical incision called laparotomy

    Before the surgery, you will receive spinal morphine anesthesia (medication injected into your spine) for pain control

  2. Step 2

    Surgery and medication administration

    During the surgery, you will receive either intravenous lidocaine (a pain medication) or a placebo (inactive substance)

    Neither you nor your doctor will know which substance you are receiving

    The surgery duration will be measured from the first cut to final closure

  3. Step 3

    Post-surgery monitoring (0-12 hours)

    You will be moved to a recovery room for monitoring

    Your pain levels will be checked every 4 hours using a pain scale from 0 to 10

    You will have access to additional pain medication (morphine) through a button you can press when needed

    Medical staff will monitor for any medication-related effects

  4. Step 4

    Continued monitoring (12-96 hours)

    Your pain levels will continue to be checked every 4 hours

    Staff will record when you first pass gas after surgery

    Your first time getting out of bed will be documented

    Your use of pain medication will be tracked

    Any medication-related effects will be monitored and recorded

  5. Step 5

    Hospital stay and follow-up

    Your total hospital stay duration will be recorded

    Medical staff will continue monitoring your recovery and any effects from the medications

    Your participation in the study ends after 96 hours (4 days) of monitoring

Who can join the trial?

13 criteria

  • Must be 18 years or older
  • Scheduled for major digestive or abdominal surgery, which may include:
    • Pancreatic surgery
    • Liver surgery
    • Colorectal surgery
    • Gynecological surgery
    • Surgery of the esophagus (food pipe)
    • Stomach surgery
    • Small intestine surgery
    • Surgery must be planned in advance (not emergency)
    • Surgery must be performed through laparotomy (a large incision in the abdomen)
    • Must agree to receive spinal anesthesia with morphine (medication injected into the spine to prevent pain during surgery)
    • Must be enrolled in a social security scheme
    • Must provide signed informed consent (written agreement to participate in the study)

Who cannot join the trial?

15 criteria

  • Age below 18 or above 75 years
  • Known allergy or hypersensitivity to lidocaine (a local anesthetic medication)
  • Presence of severe heart rhythm problems or heart conduction disorders
  • Severe liver disease that affects liver function
  • Severe kidney disease that affects kidney function
  • Pregnancy or breastfeeding
  • History of chronic pain requiring regular pain medication
  • Unable to understand or follow study instructions
  • Current participation in another clinical trial
  • History of substance abuse or addiction
  • Presence of any condition that would make spinal anesthesia (injection of medication near the spine) unsafe
  • Emergency or unplanned surgery
  • Previous adverse reaction to morphine (a strong pain medication)
  • Severe mental health conditions that could affect participation
  • Uncontrolled high blood pressure
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Investigated drugs

  • Lidocaine

    is a local anesthetic medication given through an intravenous (IV) line directly into the bloodstream. It helps reduce pain and is commonly used during and after surgery. In this trial, it is being tested to see if it can help reduce the need for other pain medications after major abdominal surgery.

  • Morphine

    is a strong pain medication that belongs to the opioid family. In this trial, it is given through spinal anesthesia (injected into the spine) to help control pain during and after abdominal surgery. This method of delivery is called intrathecal or spinal morphine administration.

What is already known about the treatment

  • Lidocaine

    A local anesthetic medication administered intravenously in combination with spinal morphine anesthesia for major gastrointestinal and abdominal surgery. This medication belongs to the class of sodium channel blockers and works by temporarily blocking nerve signals in the body, helping to reduce postoperative pain and decrease the need for additional morphine consumption after surgery. Lidocaine's intravenous administration in this context represents an innovative approach to multimodal pain management, with clinical trials investigating its potential benefits in reducing overall opioid requirements during the first 48 hours following major surgical procedures.

  • Morphine

    A powerful opioid analgesic administered through spinal (intrathecal) injection for pain management during and after major abdominal surgery. As a member of the opioid class of medications, morphine works by binding to specific receptors in the central nervous system to provide strong pain relief during surgical procedures. When administered through spinal anesthesia, it provides targeted pain control with lower doses compared to other routes of administration, making it an effective choice for major surgical procedures requiring laparotomy.

Investigated diseases

Based on the provided source data, I can identify one relevant medical condition to describe: Post-operative Pain - A condition that occurs after major abdominal or gastrointestinal surgery. It develops immediately following surgical procedures and can persist for several days. The pain intensity typically varies depending on the type and extent of surgery performed. This condition affects the patient's ability to move, cough, and perform other physical activities. It may also impact the patient's breathing patterns and delay recovery of normal gastrointestinal function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521206-18-00Protocol codeLIDORACHIEstimated enrolment76 patientsSponsorGCS Ramsay Sante Enseignement Et Recherche

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