AuthorisedTherapeutic use (Phase IV)Interventional

Placebo-controlled double-blind trial of the analgesic effect and safety of clonidine in patients after major abdominal surgery

This research study, for people having major bowel surgery for cancer, is testing a medicine called clonidine. The main goal is to see if taking clonidine after surgery can help manage pain and reduce the amount of strong pain relief (like morphine) people need. Researchers also want to check how safe clonidine is and how well patients recover. This type of study, called a 'phase 4' trial, helps us learn more about medicines that are already approved but are being used in new ways or to gather more details on their effects in real-world settings. It's a 'double-blind' study, meaning neither patients nor their doctors will know if they're receiving clonidine or a dummy pill (placebo) until the study is over.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Esbjerg Og Grindsted Sygehus

Enrolment target

182

Start

17 Dec 2024

Trial participants are having colectomy due to cancer

What is this study about?

This study is designed to help us understand if a medicine called clonidine can make a difference for people recovering from a major operation called a colectomy, which is surgery to remove part of the bowel, often due to cancer. After big operations, managing pain is really important, and strong painkillers like morphine are often used. We want to find out if giving clonidine can help reduce the amount of morphine needed to keep patients comfortable in the 24 hours after their surgery. This could potentially lead to better pain control with fewer side effects associated with strong painkillers.

To ensure we get clear answers, this study is 'double-blind.' This means that during the trial, neither you nor your care team will know if you're receiving the active medicine (clonidine) or a placebo (a dummy pill with no active ingredient). This helps prevent any bias from affecting the results. It's also 'placebo-controlled,' meaning we're comparing clonidine's effects against a placebo, which is the best way to tell if any improvements are genuinely due to the medicine.

Beyond simply measuring pain relief, we'll also be looking at several other things. This includes how your body reacts to the medication, such as your blood pressure and heart rate, and even looking at certain genetic information from your blood samples. This helps us understand if some people might respond differently to clonidine based on their body's make-up. All of this information helps us build a complete picture of clonidine's role in pain management after major surgery.

Key takeaways

This study explores a new way to manage pain after major bowel cancer surgery.
It tests if clonidine can reduce the need for strong painkillers like morphine.
The study compares clonidine to a placebo (dummy pill) to see its true effect.
Your pain will continue to be managed by your medical team.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning older adults are welcome to participate if they meet all other criteria.

Participants must be preparing to have major surgery for bowel cancer, specifically an operation called a colectomy. This is a very important requirement, as the study is focused on pain relief after this particular type of surgery.

Both men and women can join this study. We look at everyone fairly to make sure the study results are helpful for all patients who might have this surgery in the future. Specific medical conditions or other medications you are taking might affect whether you can join, but the initial requirements are quite broad.

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 to have bowel surgery (colectomy) due to cancer?
Are you comfortable with the possibility of receiving either the study drug or a placebo?
Are you willing to have blood samples taken and your vital signs monitored?
Are you open to filling out short questionnaires about your pain?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned either the study medicine (clonidine) or a placebo (a dummy pill). Neither you nor your doctors will know which one you're receiving. The main focus is on how much morphine you need for pain relief in the 24 hours immediately after your colectomy surgery.

Throughout the study, we'll collect information on your pain levels using simple scales, similar to rating your pain from 0 to 10. You might also be asked to fill out short questionnaires. We'll take regular measurements of your vital signs like blood pressure, heart rate, and oxygen levels. There will also be some blood samples taken to measure the levels of clonidine and other painkillers in your system, as well as to look at certain genetic markers. We'll also gather general information about your health, medical history, and physical condition. The total duration of active participation is relatively short, focusing on the immediate post-operative period.

Potential risks and benefits

Taking part in this study might mean you get better pain control or need less strong pain medication after your surgery, which could improve your recovery. However, there's no guarantee the study medicine will work for everyone, and you might receive a placebo. Like all medicines and medical procedures, there are potential risks, including possible side effects from clonidine, although it's an approved drug. Some people might experience low blood pressure or tiredness. You will be closely monitored by your medical team throughout the study for any side effects. 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
Denmark

Common questions

What is clonidine?

Clonidine is a medicine that can affect how your body responds to pain. In this study, we're testing if it can help reduce pain after surgery.

What is a 'placebo-controlled, double-blind' study?

This means some people get the actual medicine and some get a dummy pill (placebo), and neither you nor your doctor will know who gets what. This helps ensure fair and accurate results.

Why is this study only for people having bowel surgery for cancer?

The study focuses on this specific surgery because pain management can be particularly challenging, and we want to see if clonidine can help this group of patients.

Will I still get pain relief if I'm in the study?

Yes, absolutely. Your medical team will ensure your pain is managed throughout your recovery, regardless of whether you receive clonidine or the placebo.

What if I change my mind about participating?

You are free to leave the study at any time without giving a reason, and it will not affect the quality of your medical care.