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Efficacy of Intravenous Lidocaine versus Sodium Chloride in Reducing Postoperative Pain for Patients Undergoing Emergency Abdominal Surgery

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What is this trial about?

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

The study focuses on patients who need emergency abdominal surgery, a rapid operation on the belly organs performed when urgent medical problems arise. The investigation compares an infusion of lidocaine, a medication that numbs nerves, given intravenously during the operation, with a placebo solution of saline. The purpose of the study is to determine whether continuous lidocaine given during the operation can lower the amount of chronic pain that persists six months after the surgery.

Participants are randomly assigned, meaning the decision is made by chance, to receive either the lidocaine or the saline, and the trial is double‑blind so neither the care team nor the patients know which one is given. After the operation, pain is measured using a simple number scale from 0 (no pain) to 10 (worst pain) at several time points up to six months, along with questionnaires about daily activities and overall well‑being. The study follows each person for about half a year to see how the treatment affects long‑term pain and recovery.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Consent and baseline assessment

    After agreeing to join the study, you will sign a consent form that explains the purpose and procedures.

    Initial information about your health, pain level, and any medications you are taking will be recorded.

  2. Step 2

    Random assignment to treatment

    You will be randomly placed into one of two groups without knowing which group you are in.

    One group receives an intravenous infusion of lidocaine, the other receives an infusion of saline solution (sodium chloride) that looks the same.

  3. Step 3

    Setup of intravenous line before surgery

    A small tube (intravenous line) will be inserted into a vein in your arm or hand before the emergency abdominal operation begins.

    The line will be used to deliver the study medication continuously during the operation.

  4. Step 4

    Continuous infusion during surgery

    Once the operation starts, the infusion pump will deliver the assigned medication at a steady rate.

    If you are in the lidocaine group, the pump will deliver lidocaine at a dose of 120 milligrams per hour.

    If you are in the placebo group, the pump will deliver 0.18 gram of sodium chloride (saline) at the same rate.

    The infusion continues for the entire duration of the surgery and stops when the surgeon closes the abdomen.

  5. Step 5

    Post‑operative pain monitoring in hospital

    After the operation, nurses will check your pain level regularly using a simple 0–10 numeric scale.

    Pain medication such as acetaminophen or other common pain relievers may be given as needed, and the amount used will be recorded.

  6. Step 6

    Follow‑up assessments at 3 months

    Three months after the surgery, you will be asked to complete questionnaires about pain intensity, how pain interferes with daily activities, and quality of life.

    You will also report any pain medicines you are still using.

  7. Step 7

    Final assessment at 6 months

    Six months after the operation, the same set of questionnaires will be repeated.

    The primary outcome is whether your average abdominal pain during the week before the visit is rated 4 or higher on the 0–10 scale.

    All medication use and any side effects will be collected.

Who can join the trial?

7 criteria

  • You are at least 18 years old and younger than 80 years old.
  • You need to be having an emergency or semi‑emergency abdominal surgery that involves the urinary system, the digestive system, or the female reproductive system.
  • The surgery can be done as an open surgery (a larger cut) or a laparoscopic surgery (small keyhole cuts with a camera).
  • The operation is expected to last at least 60 minutes (one hour).
  • You must be able to give informed consent (agree to join the study). If you cannot, a family member or legal representative can give consent, and you will be asked again after the surgery.
  • Both men and women are eligible to participate.
  • People who may be considered vulnerable (for example, those who have difficulty making decisions) can join, as long as proper consent is obtained.

Who cannot join the trial?

13 criteria

  • Using an epidural (a type of regional anesthesia that numbs the lower back) to control pain.
  • Being pregnant or breastfeeding.
  • Having porphyria (a rare disorder that affects how the body makes certain chemicals).
  • Having surgery that is part of an organ transplant.
  • Having any of the following problems that make lidocaine unsafe: known allergy to lidocaine or similar medicines, complete heart block (the heart’s electrical signals are completely stopped), or low blood volume (not enough fluid in the bloodstream).
  • Having any of the following problems that make normal saline (0.9% NaCl) unsafe: high blood chloride (hyperchloremia), high blood sodium (hypernatremia), or severe fluid overload or water‑sodium retention, especially if you have advanced heart failure, advanced liver disease with swelling (edematous‑ascitic cirrhosis), or pregnancy‑related high blood pressure problems (preeclampsia/eclampsia).
  • Being under legal guardianship, conservatorship, or other court‑ordered protection.
  • Having an untreated serious heart rhythm problem called a high‑degree atrioventricular block or taking long‑term Class I anti‑arrhythmic drugs (medicines that affect heart rhythm).
  • Being in shock, which means a systolic blood pressure of 90 mmHg or lower when you arrive for emergency surgery.
  • Having respiratory failure, defined as breathing faster than 25 breaths per minute or an oxygen level below 90% on a pulse‑oximeter when you arrive.
  • Having neurological failure, shown by a Glasgow Coma Scale score of 13 or lower when you arrive (a test that measures eye, verbal and motor responses).
  • Having a known diagnosis of dementia (significant memory and thinking problems).
  • Being an active drug user or currently going through drug withdrawal.
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Investigated drugs

Lidocaine is a medication that numbs nerves and reduces pain. In this study, it is given continuously through an IV line during emergency abdominal surgery. The goal is to see if this steady infusion can lower the amount of chronic pain patients feel after the operation and reduce other complications up to six months later. The drug works by blocking pain signals in the body, which may help patients recover more comfortably after their surgery.

What is already known about the treatment

  • Sodium chloride

    This medication is given as an intravenous injection of a 0.9 % saline solution, which means the fluid is poured directly into a vein using a syringe or infusion set. It is a standard, widely used medical product that has been established for many decades and is listed in all major drug references. The main uses are to replace lost body fluids, correct low salt levels, and in clinical trials it often serves as a harmless placebo. It works by adding sodium and chloride ions to the blood, helping to keep the body’s fluid balance normal, and is classified as an electrolyte solution and volume expander.

  • Lidocaine

    This drug is administered as a continuous intravenous infusion, meaning a small amount is steadily delivered into a vein through a pump during surgery. Lidocaine is an approved medication that has been used for many years as a local anesthetic and is also studied for pain relief after surgery. It is mainly used to numb tissue during procedures and to reduce pain after operations, especially in abdominal surgery. The drug works by blocking sodium channels in nerve cells, which stops pain signals from traveling, and it belongs to the class of local anesthetics (also classified as a class 1b anti‑arrhythmic).

Investigated diseases

Acute abdomen - It is a sudden onset of severe abdominal pain that signals a serious problem inside the belly. The pain often spreads and may be accompanied by tenderness, swelling, and a feeling of fullness. As the underlying cause worsens, inflammation can spread to the lining of the abdomen, leading to fluid buildup. If the problem continues, the affected organs may begin to lose function and the overall condition can become more widespread. The situation typically evolves quickly, requiring prompt medical attention to stop further deterioration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523682-24-00Protocol codeRC25_0291Estimated enrolment266 patientsSponsorCentre Hospitalier Universitaire De Nantes

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