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Efficacy of sufentanil versus fentanyl for postoperative pain in patients undergoing urgent laparoscopic cholecystectomy

Fast replyRegistered drugNo placebo
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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 an urgent laparoscopic cholecystectomy, a short operation that removes the gallbladder through a few small cuts. During the operation, the pain‑relieving medicine sufentanil will be given through an intravenous (into a vein) line using a steady, computer‑controlled flow, and its effectiveness will be compared with the standard opioid fentanyl that is normally used for this type of surgery. The purpose of the study is to determine whether the new method provides pain control that is not worse than the usual treatment.

Participants will receive one of the two medicines while they are under anesthesia for the surgery. After the operation, they will stay in the recovery area and be asked to rate their pain at several times during the first day. Pain will be measured with the Visual Analogue Scale, a simple line where patients mark how strong their pain feels, from “no pain” to “worst pain imaginable.” Researchers will also watch for common side effects such as nausea, itching, or breathing problems.

The follow‑up period lasts about 24 hours, during which the amount of additional pain medication needed and any unwanted reactions will be recorded. At the end of the study, the collected information will help decide if the new medication method can be used as an alternative to the current standard for managing pain after this surgery.

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

    Enrollment and baseline assessment

    After agreeing to participate, basic information such as age, sex, weight, height, and health status is recorded.

    The information is used to compare the two medication groups during the study.

  2. Step 2

    Preoperative preparation

    You are taken to the operating room for urgent laparoscopic cholecystectomy, a minimally invasive surgery to remove the gallbladder.

    Standard monitoring devices are attached to track vital signs.

  3. Step 3

    Intraoperative medication administration

    Depending on random assignment, either sufentanil or fentanyl is given through an intravenous line.

    sufentanil is delivered as a 75 µg dose using a concentration‑targeted continuous intravenous infusion (tci) model, which aims to keep a steady drug level.

    fentanyl is delivered as a 750 µg dose as a bolus injection or continuous infusion according to the hospital’s usual practice.

    The medication is administered only during the surgery and stops when the operation is finished.

  4. Step 4

    Postoperative pain assessment

    After surgery, pain is measured using the visual analogue scale (vas), a line marked from 0 (no pain) to 10 (worst pain).

    Vas is recorded at the first postoperative hour, the second hour, the twelfth hour, and again at 24 hours.

    These measurements are used to compare the effectiveness of the two drugs.

  5. Step 5

    Postoperative medication monitoring

    Any additional opioid medication given during the first 24 hours is recorded in micrograms.

    The amount of opioid used is compared between the two groups.

    Side effects such as nausea, vomiting, itching, or breathing difficulty are also noted.

  6. Step 6

    Study completion

    After the 24‑hour monitoring period, the data collection for your participation ends.

    No further study‑related procedures are required.

Who can join the trial?

5 criteria

  • Be at least 18 years old (you must be an adult).
  • Have an ASA Classification of I, II, or III – this is a simple rating of your overall health before surgery, where I means healthy, II means mild health issues, and III means more serious health problems.
  • Be scheduled for an urgent laparoscopic cholecystectomy – a quick, minimally invasive operation to remove the gallbladder.
  • Agree to take part by signing the Informed Consent form, which explains the study and your rights in easy‑to‑understand language.
  • Be either male or female – the study includes all adults regardless of gender.

Who cannot join the trial?

7 criteria

  • Having a known allergy to the pain medicines fentanyl or sufentanil, which means your body reacts badly to these drugs.
  • Being classified as ASA IV or V, a rating that indicates very serious overall health problems that make surgery high‑risk.
  • Regularly using strong pain medicines (opioids) such that the amount of morphine you would take each day is more than 10 milligrams, known as a high oral morphine equivalent dose.
  • Having a mental health (psychiatric) or brain (neurological) condition that makes it difficult for you to work with the study staff or to use the pain‑rating tool called the EVA scale (a simple way to mark how much pain you feel).
  • Having severe failure of the kidney or liver, meaning these organs are not working well enough.
  • Having moderate lung (pulmonary) disease or needing to use oxygen at home, which indicates breathing problems.
  • Being pregnant or currently breastfeeding, because the study drugs could affect the baby.
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Investigated drugs

  • Sufentanil

    is a strong pain‑relieving medication that was given to patients during the surgery. In this study it was delivered through an intravenous line using a special computer‑controlled infusion that aims to keep a steady level of the drug in the blood. The researchers wanted to see if using sufentanil in this way could control pain after the operation as well as, or better than, the usual pain medicines.

  • Fentanyl

    is another powerful pain‑relieving drug that is commonly used in hospitals. In the trial it was given to patients after the surgery according to the standard practice at the hospital. The study used fentanyl as the comparison treatment to determine whether the new sufentanil method was at least as effective for controlling postoperative pain.

What is already known about the treatment

  • SUFENTANIL

    This medication is given as an intravenous (IV) bolus injection or continuous IV infusion during surgery. It is a well‑known, approved opioid that is widely used in anesthesia and for managing pain after operations. It works by attaching to specific receptors in the brain and spinal cord, which reduces the feeling of pain. Sufentanil belongs to the class of synthetic opioid analgesics.

  • FENTANYL

    This drug is also administered as an IV bolus injection or IV infusion during surgical procedures. It is an established, approved opioid commonly used for anesthesia and postoperative pain relief. It reduces pain by binding to the same receptors in the nervous system that control pain signals. Fentanyl is classified as a synthetic opioid analgesic.

Investigated diseases

  • Acute cholecystitis

    Inflammation of the gallbladder, usually caused by a gallstone blocking the cystic duct. Pain begins in the upper right abdomen and may spread to the shoulder. The inflammation can worsen over hours to days, leading to swelling, fever, and tenderness. If untreated, the gallbladder wall may become damaged. The condition often requires urgent removal of the gallbladder.

  • Cholelithiasis

    Formation of solid stones inside the gallbladder. Stones may be small or large and can stay without symptoms. When a stone blocks the bile flow, it can cause pain, nausea, and inflammation. Repeated blockage can lead to chronic irritation and infection. Over time, the gallbladder may become dysfunctional.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525783-18-00Protocol codeSUFEN_VIGO_2026Estimated enrolment66 patientsSponsorFundacion Biomedica Galicia Sur

sourced from the EU Clinical Trials Register and site verification

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