AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efficacy of sufentanil in urgent laparoscopic cholecystectomy: An alternative to the usual opioids for postoperative pain?

This research is comparing two different pain medicines, sufentanil and fentanyl, for people having a common keyhole operation to remove their gallbladder. The main goal is to find out if sufentanil works better than fentanyl at reducing pain immediately after surgery. Researchers will use a simple pain scale to measure this. They will also look at whether sufentanil causes fewer problems like feeling sick, itching, or breathing difficulties, and how much pain relief people need over the first 24 hours. The study aims to see if sufentanil could be a good alternative to the usual pain medicines used after this type of surgery.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Biomedica Galicia Sur

Enrolment target

Start

08 Jun 2026

Laparoscopic cholecystectomy

What is this study about?

Imagine you need an operation to remove your gallbladder, which is often done using a 'keyhole' method called laparoscopic cholecystectomy. After any surgery, pain relief is really important for your comfort and recovery. Doctors often use strong medicines called opioids for this, but sometimes these can cause side effects like feeling sick or itchy.

This particular study is like a comparison test between two different opioid pain medicines: sufentanil and fentanyl. Fentanyl is a common pain medicine used during and after surgery. The researchers want to know if sufentanil might be a better option. They will be looking closely at how well each medicine controls pain right after the operation, using a simple scale where you rate your pain.

They will also be checking for other important things. This includes whether people feel sick or vomit, if they get itchy, or if they have any breathing problems. They'll also keep track of how much pain medicine you need in total over the first day after surgery. The aim is to see if sufentanil could provide good pain relief with potentially fewer unwanted effects, helping people recover more comfortably after their gallbladder surgery.

Key takeaways

Compares two pain medicines, sufentanil and fentanyl, for gallbladder surgery.
Aims to find out which medicine offers better pain relief after surgery.
Also looking for fewer side effects like sickness or itching.
Participation involves routine checks and answering pain questions for 24 hours after surgery.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 or older. There is no upper age limit, meaning anyone over 18 can be considered.

The study is open to both men and women, so your sex doesn't affect whether you can join.

Basically, if you're an adult scheduled for keyhole gallbladder surgery, you might be able to participate. The doctors will check a few other things to make sure the study is safe and right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for keyhole gallbladder surgery?
Are you a man or a woman (both can participate)?
Are you generally in good health otherwise?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won’t have extra hospital visits. It will be part of your planned keyhole gallbladder surgery. During and after your operation, doctors will give you either sufentanil or fentanyl, and you won't know which one. They will regularly ask you to rate your pain using a simple scale called a Visual Analogue Scale (VAS). This involves pointing to a number on a line that best describes your pain level. They'll ask about your pain at 1, 2, and 12 hours after your surgery. Doctors will also check for common side effects like feeling sick, vomiting, itching, or any breathing difficulties. Your weight, height, and some other health details will be noted before surgery, and they'll keep track of how much pain medicine you need in the first 24 hours. The total duration of your active participation, for measurements and observations, will be for the first 24 hours after your surgery.

Potential risks and benefits

Taking part might mean you receive a pain medicine that could offer better pain control or fewer side effects than usual, which could help your recovery. However, like all medicines, both sufentanil and fentanyl have potential side effects, including feeling sick, dizziness, or breathing problems, though these will be closely monitored. There's no guarantee which medicine you'll receive or that it will be better for you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a 'keyhole' gallbladder surgery?

It's a common operation where doctors remove your gallbladder using several small cuts instead of one large one, helping you recover faster.

What is a Visual Analogue Scale (VAS)?

It's a simple way to measure your pain. You'll be asked to point to a number on a line, usually from 0 (no pain) to 10 (worst possible pain), to show how much pain you feel.

Will I know which pain medicine I'm getting?

No, in this study, neither you nor your doctors will know if you're receiving sufentanil or fentanyl. This helps ensure the results are fair.

What are opioids?

Opioids are strong pain medicines often used after surgery to help manage moderate to severe pain. They can be very effective but can also have side effects.

What happens if I feel unwell during the study?

Your medical team will be closely monitoring you and will always provide the best care for you, regardless of your participation in the study. You can also withdraw at any time.