RecruitingPhase IVInterventional

Pain management using ibuprofen after major gut surgery (PROTECT-AEGIS)

Doctors are unsure whether ibuprofen is safe and helpful for pain after major tummy surgery. While ibuprofen is a common painkiller, some older research suggested it might lead to complications like stomach ulcers or kidney issues for patients who've had gut surgery. However, newer studies don't show the same worries. This small study aims to find out if patients and doctors are comfortable taking part in research about ibuprofen after surgery. If this first step goes well, we plan a larger study to get a clear answer on whether ibuprofen can safely provide better pain relief for people recovering from major gut surgery, helping them recover more comfortably and potentially reduce hospital stays.

At a glance

Status

Recruiting

Phase

Phase IV

Sponsor

Queen Mary University of London

Enrolment target

200

Start

17 Mar 2026

Estimated completion

01 Dec 2026

Pain management for patients undergoing major gastro-intestinal surgery

What is this study about?

When you have major gut surgery, pain is expected, and doctors work hard to manage it. Ibuprofen is a widely available pain medicine that's very good at reducing pain. However, even though it's common, doctors aren't sure if it's always safe to give after major tummy operations. This is because some past studies hinted it might cause problems like stomach ulcers or issues with gut healing or kidneys. But other, newer studies didn't find these risks, leaving doctors uncertain.

This small study, called PROTECT-AEGIS, wants to clear up this confusion. We're testing the waters to see if patients and doctors are happy to be involved in a study to look at this more closely. We need to find out if people feel comfortable taking ibuprofen after surgery as part of a research study, with careful monitoring. If this works, we can then run a much bigger study to definitely prove whether ibuprofen is truly helpful and safe for pain relief after major gut surgery, or if it isn't. Our goal is to give patients the best possible pain control and help them recover faster.

Ultimately, this research could lead to better ways to manage pain for the thousands of patients undergoing major gut surgery in the UK each year, helping them feel more comfortable and potentially spend less time in hospital.

Key takeaways

The study aims to see if ibuprofen is safe and effective for pain after major gut surgery.
It's a small first step to help doctors decide on a larger study.
Participation involves being randomly assigned to receive ibuprofen plus standard care, or just standard care.
Your pain levels and health will be closely monitored, with a final check-in 30 days post-surgery.
Only patients at low risk of ibuprofen side effects will be considered.
You can withdraw from the study at any time without affecting your NHS care.

Who may be eligible?

You might be able to take part if you are aged 18 or over and are having major stomach or bowel surgery that involves joining parts of your gut back together. This surgery must be planned in advance (not an emergency).

However, you will not be able to join the study if you have certain health conditions. This includes if you have very serious organ problems, have had stomach ulcers or bleeding more than once, or if you are allergic to ibuprofen or similar medicines. You also can't take part if you're taking another type of anti-inflammatory medicine, or if you're in your third trimester of pregnancy.

The study team will carefully check all these points with you to make sure it's safe for you to take part.

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 (not emergency) major gut surgery where parts of your bowel are reconnected?
Do you have any serious organ problems, like severe kidney disease?
Have you ever had two or more stomach ulcers, or bleeding from ulcers?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups by chance, like flipping a coin – neither you nor your doctor can choose. One group will receive ibuprofen in addition to the usual pain relief medicines for five days after your surgery. The other group will only receive the usual pain relief. The usual pain relief often includes strong painkillers like morphine-like medicines, pain relief given directly into your wound, or paracetamol.

If you're in the ibuprofen group, you'll also get medicine to protect your stomach. All your other treatments will be the same, no matter which group you're in. Your doctors will know you're in the study and will watch you closely to ensure your safety. We'll also ask you simple questions about your pain every day for five days – this will only take about two minutes. You might answer these online, by phone, or in person if you're still in hospital. We'll contact you one last time 30 days after your operation to check in. Your GP will also be informed that you took part.

Potential risks and benefits

We will only include patients who are at a low risk of side effects from ibuprofen. If you receive ibuprofen, it will be used in a way that is approved for use in the UK. The potential benefit is that ibuprofen might give you better pain relief after your surgery, helping you to recover more comfortably. Your health will be carefully watched throughout the study to make sure you are safe. Remember, you can choose to leave the study at any time without it affecting your medical care.

Locations (13)

Barts Health NHS Trust
City only
London, England
The Royal Marsden Hospital
Approximate
London, England
University Hospitals Birmingham NHS Foundation Trust
City only
Birmingham, England
University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Croydon Health Services NHS Trust
City only
Thornton Heath, England
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Unverified
Newcastle upon Tyne, England
Leeds Teaching Hospitals NHS Trust
Unverified
Leeds, England
NHS Grampian
Unverified
Aberdeen, Scotland
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England
Manchester University NHS Foundation Trust
Unverified
Manchester, England
South Tyneside and Sunderland NHS Foundation Trust
Unverified
Sunderland, England
York and Scarborough Teaching Hospitals NHS Foundation Trust
Unverified
York, England

Common questions

What kind of surgery is this study for?

This study is for people having planned major stomach or bowel surgery where parts of the gut are joined together.

Will I know if I'm getting ibuprofen or not?

No, it's decided randomly, like drawing lots, and neither you nor your doctor will know which group you're in until after the study is over. This helps us get fair results.

How long will I be involved in the study?

You'll receive study medication for five days after your surgery, and we'll check on your pain daily during that time. Your last contact will be 30 days after your operation.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR), which is a major funder of health research in the UK.

Can I stop taking part if I change my mind?

Yes, you are free to leave the study at any time, and this will not affect the medical care you receive.

How to find out more

Tom Abbott

t.abbott@qmul.ac.uk +44 (0)203 594 0348 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.