Active not recruitingPHASE4INTERVENTIONAL

Intraoperative Sufentanil and Chronic Postsurgical Pain in Non-major Scheduled Abdominal Surgery

This study is investigating if there's a connection between a pain medicine called sufentanil, often used during general anaesthesia for tummy operations, and whether patients experience long-lasting pain afterwards. Sometimes, after surgery, people can have ongoing pain, known as chronic postsurgical pain. This research aims to understand if the amount of sufentanil given during the operation plays a role in this type of pain three months later. While other pain medications have been studied in this way, sufentanil hasn't. The findings could help doctors better manage pain relief during surgery, improving patient comfort and reducing the risk of long-term pain for those undergoing common abdominal procedures.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Centre Hospitalier Universitaire, Amiens

Enrolment target

855

Start

24 Jun 2024

Estimated completion

01 Jul 2026

Chronic Postsurgical Pain Chronic Pain Abdominal Surgery Sufentanil Risk Factors

What is this study about?

When you have surgery, doctors give you medicine to stop you feeling pain, and some of this is given during the operation itself. This study is all about one of these pain medicines, called sufentanil, which is often used during general anaesthesia for tummy operations.

We know that some people can experience pain that lasts for a long time after surgery – this is called chronic postsurgical pain. Doctors are always looking for ways to reduce this risk. Previous research has hinted that another similar pain medicine, when given in high doses during surgery, might be linked to more long-term pain. However, no one has specifically looked at sufentanil in this way before.

This research aims to find out if there's a link between how much sufentanil is used during common, non-major tummy operations and whether patients still have pain three months later. Tummy operations are very common, and even though the risk of long-term pain from them is lower compared to some other surgeries, it still affects a fair number of people. Understanding this better could help doctors make more informed decisions about pain relief during surgery, potentially helping to reduce long-term pain for patients.

Key takeaways

This study looks at a pain medicine (sufentanil) used during tummy operations.
It aims to see if the amount of sufentanil given affects long-term pain.
Participation involves one phone interview three months after surgery.
There are no extra medicines or procedures involved for participants.
The results could help doctors improve pain management for future patients.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over, who is having a planned, non-major operation on your tummy. During your operation, the doctors must be planning to use sufentanil as part of your general anaesthetic. You'll also need to agree to take part, either in writing or verbally.

There are some reasons why you wouldn't be able to join. For instance, if you have severe complications during surgery, or if you've had surgery on the same area of your tummy less than three months ago. You also can't take part if you are pregnant, having a day-case surgery, or if your surgery is done using a small camera (endoscopic surgery). If you're having a special type of local anaesthetic where you're awake, or if doctors plan to use other strong pain medicines besides sufentanil during your operation, you wouldn't be suitable.

Additionally, you can't join if you have a known allergy to sufentanil, are under legal protection (like guardianship), or have certain mental health conditions or brain diseases that affect your nerves. It's also important that you can understand and use a simple 0-10 scale to describe your pain, so if there's a language barrier, for example, you might not be able to participate.

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 having a planned, non-major tummy operation?
Will your doctors be using sufentanil during your general anaesthetic?
Have you *not* had surgery on the same tummy area in the last 3 months?
Are you able to describe your pain on a 0-10 scale if asked?
Are you *not* pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your involvement will be quite simple. You will have a phone interview three months after your surgery. During this phone call, you will be asked about any pain you might be experiencing. The information gathered from this interview, along with details about the sufentanil you received during your operation, will help the researchers understand if there's a connection between them. There will be no extra medication, no additional hospital visits, and your total involvement will be limited to this one interview after your surgery.

Potential risks and benefits

There are no direct medical benefits for you from taking part in this study, but the information collected could help improve pain management for future patients undergoing similar surgeries. As this study only involves a phone interview after your surgery, there are no medical risks associated with participation. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

CHU Amiens-Picardie
Verified postcode
Amiens, France

Common questions

What is chronic postsurgical pain?

It's pain that continues for a long time (usually three months or more) after an operation.

What is sufentanil?

Sufentanil is a strong pain medicine given during surgery to keep you comfortable while you're under anaesthetic.

Will I get extra medicine or procedures if I join?

No, you will not receive any extra medicine or have additional procedures beyond your planned surgery if you take part.

What kind of abdominal surgery is included?

It includes planned, non-major operations on your tummy.

How long will I be involved in the study?

Your involvement is limited to a single phone interview about three months after your surgery.