Sufentanil versus fentanyl for pain control after urgent laparoscopic cholecystectomy in adult patients

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What is this study about?

The condition being studied is Laparoscopic cholecystectomy, a minimally invasive operation that removes the gallbladder through small incisions. During the operation, the pain‑relieving drug sufentanil will be given by a steady intravenous infusion, while a comparison group will receive the usual opioid fentanyl administered according to standard practice. Both medications are given through a vein and are intended to control pain after the surgery.

The purpose of the study is to determine whether the use of sufentanil provides pain relief that is not inferior to that achieved with fentanyl during the first 24 hours after surgery. Participants will be randomly assigned to receive one of the two drugs, and their pain levels will be recorded using the Visual Analogue Scale, a simple line where a mark indicates how strong the pain feels. Additional observations will include any nausea, vomiting, itching, or breathing problems, as well as the total amount of opioid medication used during and after the procedure.

1 admission for surgery

after joining the trial, you are admitted to the hospital for an urgent laparoscopic cholecystectomy.

basic information such as age, sex, weight, height and health status (asa classification) is recorded.

2 pre‑operative preparation

you receive standard pre‑operative care, which may include fasting instructions and routine safety checks.

3 surgery and intra‑operative medication

during the operation, the study medication is given through an intravenous bolus injection and a continuous infusion.

if you are assigned to the test group, you receive sufentanil at a dose of 75 µg, delivered by a concentration‑targeted continuous intravenous infusion (tci).

if you are assigned to the comparator group, you receive fentanyl at a dose of 750 µg, given as an intravenous bolus injection or infusion according to the hospital’s standard practice.

4 immediate postoperative monitoring

after surgery you are moved to a recovery area where vital signs and breathing are watched closely.

pain is measured using a visual analogue scale (vas) at the first postoperative hour.

5 pain assessments during the first day

pain scores are recorded again at the second postoperative hour and at the twelfth postoperative hour using the vas.

any additional opioid medication you receive is noted in micrograms.

6 monitoring for side effects

throughout the first 24 hours you are observed for nausea, vomiting, itching (pruritus), and signs of respiratory depression.

all observations are documented by the study team.

7 postoperative opioid use

the total amount of opioid medication you use in the first 24 hours after surgery is recorded.

8 discharge

if you meet the clinical criteria for safe discharge, you leave the hospital after the 24‑hour observation period.

no further study procedures are required after discharge.

Who Can Join the Study?

  • Age: You must be 18 years old or older.
  • ASA Classification I, II, or III: This means your overall health before surgery is considered normal (I), has mild systemic disease (II), or has moderate systemic disease (III).
  • Urgent laparoscopic cholecystectomy: You need to be scheduled for an emergency minimally‑invasive gallbladder removal surgery.
  • Signing the Informed Consent: You must agree in writing to take part in the study after understanding what it involves.

Who Cannot Join the Study?

  • Having a known allergy (a harmful reaction) to the medicines Fentanyl or Sufentanil.
  • Being classified as ASA IV or V, which means having very serious or life‑threatening health problems that affect the whole body.
  • Using strong pain medicines (opioids) regularly, with a daily dose equivalent to more than 10 mg of morphine (called an oral morphine equivalent dose over 10 mg).
  • Having a mental health or nervous‑system condition (such as severe depression, anxiety, or brain disease) that makes it impossible to cooperate with the study or to use the pain‑rating tool called the EVA scale (a simple visual pain score).
  • Having very poor kidney function or liver function, referred to as severe kidney or liver failure.
  • Having moderate lung disease (such as chronic bronchitis or asthma) or needing extra oxygen at home (moderate pulmonary pathology or home oxygen).
  • Being pregnant or breastfeeding.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Chmsidvx Hncmdmicndlf Uaxbdyoybidmj Dr Veec Vigo Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.10.2026

Trial locations

Investigated drugs:

Sufentanil is a strong pain‑relieving medicine that belongs to the opioid family. In this study it is given through an IV line during the operation, using a special technique that keeps the drug level steady (continuous infusion). The researchers are testing whether this drug can keep patients comfortable after urgent laparoscopic gallbladder removal, aiming to see if it works at least as well as the usual opioid used in the hospital.

Fentanyl is another opioid commonly used to control pain during surgery. In the trial it is administered by IV injection or infusion according to the standard practice at the hospital. It serves as the comparison drug, allowing the investigators to see if the new approach with sufentanil provides similar or better pain relief after the operation.

Acute cholecystitis – Acute cholecystitis is the sudden inflammation of the gallbladder, usually caused by a blockage of the bile duct by gallstones. The blockage leads to a buildup of bile, which irritates the gallbladder wall and triggers swelling. Symptoms often begin with sharp pain in the upper right abdomen that may spread to the back or shoulder. The inflammation can cause the gallbladder to become tender, and the pain may worsen after eating fatty meals. Over time, the swelling can increase, making the pain more persistent and sometimes accompanied by a mild fever.

Gallstone disease – Gallstone disease refers to the formation of solid particles, called gallstones, within the gallbladder. These stones develop when bile components harden, often because of excess cholesterol or bilirubin. Small stones may pass unnoticed, but larger ones can block the flow of bile. When a stone blocks the bile duct, it can cause sudden abdominal pain, especially after meals. Repeated blockage can lead to repeated episodes of discomfort and irritation of the gallbladder.

Trial ID:
2026-525783-18-00
Protocol code:
SUFEN_VIGO_2026
Trial Phase:
Therapeutic confirmatory (Phase III)

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