Not yet recruitingNAINTERVENTIONAL

Rectus Sheath Catheters Following Midline Laparotomy

This study is about finding better ways to manage pain after major tummy surgery. Doctors are testing a method where small, thin tubes, called rectus sheath catheters, are placed in the tummy muscles during surgery. Through these tubes, pain-numbing medicine can be given directly to the nerves in the area. This is being compared to a dummy treatment (placebo) to see if it significantly reduces pain, helps people recover better, and lowers the need for strong pain medications like opioids in the first three days after surgery. This approach could be especially helpful for people who can't have other types of pain relief, such as an epidural.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Asklepios Kliniken Hamburg GmbH

Enrolment target

Start

01 Jul 2025

Estimated completion

01 Sep 2027

Acute Abdomen Ileus Colorectal Carcinoma

What is this study about?

When you have a big operation on your tummy, like for conditions such as bowel cancer or a severe stomach problem, managing pain afterwards is really important. Doctors want to make sure you're as comfortable as possible so you can recover well and get back on your feet sooner. Sometimes, strong pain medications are needed, but these can have side effects. That's why researchers are always looking for new and better ways to control pain.

This study focuses on a technique that uses special little tubes, called rectus sheath catheters, which are put into the muscles of your tummy during the surgery, just before the wound is closed. These tubes allow pain-numbing medicine to be given very close to the nerves that carry pain signals from your tummy. This might block the pain messages more effectively right at the source, without affecting your whole body as much as medications you take by mouth or injection.

The main aim of this research is to see if this method, when used alongside other standard pain relief, works better than just the standard pain relief and a dummy treatment. The study will measure things like your pain levels, how well you're recovering overall, and how much strong pain medication you need in the first three days after your operation. This information will help doctors understand if this technique truly helps people feel better and recover faster after tummy surgery.

Key takeaways

This study aims to improve pain relief after major tummy surgery.
It tests a method using small tubes to deliver pain medicine directly to tummy nerves.
The goal is to see if it reduces pain, helps recovery, and lowers the need for strong painkillers.
It's being compared to a 'dummy' treatment to find out if it truly makes a difference.
Participants will have their pain, recovery, and pain medication use carefully monitored for 3 days.

Who may be eligible?

To join this study, you would need to be having a specific type of major tummy operation called a midline laparotomy. You also need to be 18 years old or older and be able to give your full permission to take part.

There are also some reasons why you wouldn't be able to join. For example, if you have any signs of infection where the tubes would be placed, or if you've had an allergic reaction to pain-numbing medicines in the past. If you already suffer from long-term pain, have a drug addiction, or are taking part in another medical study, you wouldn't be eligible. Also, if you're pregnant, have a severe body-wide infection (sepsis), or if doctors expect you'll need to stay on a breathing machine for longer than the day of your surgery, you wouldn't be able to join. Finally, if you're unable or unwilling to cooperate with the study requirements, you wouldn't be included.

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.

Am I having a midline laparotomy (major tummy surgery with a cut down the middle)?
Am I 18 years old or older?
Do I have any allergies to local pain-numbing medicines?
Do I have any ongoing infections around my tummy?
Am I able to understand the study and willing to cooperate fully?
Am I pregnant or taking part in another medical study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your recruitment would start during your pre-surgery anaesthesia appointment. Once you've read and understood all the information and given your consent, you'll be included. On the day of your surgery, before your operation, you'll be randomly assigned to one of two groups: either receiving the real pain-numbing medicine through the catheters or receiving a dummy solution (placebo). Neither you nor the doctors involved in your care will know which treatment you are getting.

During your operation, after the main surgery is done but before your wound is fully closed, the doctors will carefully place the small tubes (catheters) into your tummy muscles using an ultrasound machine to guide them. Once the tubes are in, you'll receive either the study medication or the placebo through them. Throughout your hospital stay, especially for the first 72 hours, the study team will closely monitor your pain levels, how you're recovering, and how much pain medication (including strong opioids) you need. There are no extra hospital visits beyond your normal recovery, and the tubes are typically removed after a few days.

Potential risks and benefits

Potential benefits of taking part could include better pain control after your surgery, which might lead to a more comfortable recovery and potentially a reduced need for strong pain medications. However, it's also possible that the pain relief from the study medication might not be more effective than the placebo. As with any medical procedure, placing the catheters carries a small risk, such as bruising, bleeding, or infection at the insertion site. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Asklepios Medical Center Uckermark
Verified postcode
Schwedt, Germany

Common questions

What is a midline laparotomy?

It's a type of surgery where doctors make an incision (cut) down the middle of your tummy to access organs inside. This is done for various medical conditions.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used to fairly compare if the real medicine is actually working.

Why don't I know if I'm getting the real medicine or the placebo?

This is called 'blinding' and it's important so that neither you nor your doctors are influenced by knowing what treatment you're receiving. This makes the study results more reliable.

Will I still get other pain relief?

Yes, this study is testing the rectus sheath catheters as an *additional* pain relief method. You will still receive standard pain relief medications, like paracetamol and other pain medicines, as needed.

Is this a new treatment?

The general idea of using catheters for pain relief isn't new, but this study specifically looks at whether this particular method provides a significant *additional* benefit for pain management after tummy surgery compared to standard care plus a placebo.

How to find out more

Ronald Seidel, Dr.med.

ro.seidel@asklepios.com +49 3332 534521 Official trial record

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