RecruitingNAINTERVENTIONAL

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

This research study is comparing two different pain relief methods used after a type of major stomach surgery called a laparotomy. This surgery is often done for serious conditions, like cancer. The aim is to see which pain relief technique helps people recover quicker and with less discomfort. One method is an epidural, which is a common way to control pain. The other is a newer technique called a bilateral rectus sheath block, which involves placing thin tubes near the tummy muscles to deliver pain medicine. The study will look at how these methods affect a patient's overall recovery and well-being after their operation. They want to find the best way to help people get back on their feet faster, with fewer side effects from pain relief.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Régional Metz-Thionville

Enrolment target

110

Start

11 Oct 2021

Estimated completion

10 Apr 2029

Laparotomy

What is this study about?

When you have a big operation on your tummy, like a laparotomy, managing pain afterwards is really important. Good pain relief helps you move around sooner, breathe more easily, and generally recover faster. This study is looking into different ways to achieve good pain relief without too many unwanted side effects. The ultimate goal is to improve what's called 'fast-track recovery,' especially for patients having surgery for conditions like cancer.

Currently, epidurals are often used. An epidural involves a small tube placed in your back to deliver pain medicine. While very effective, epidurals can sometimes have mild side effects. Researchers are interested in whether a newer approach, called a bilateral rectus sheath block, could be just as good at controlling pain, but with fewer complications. This block involves placing small tubes near the front tummy muscles to deliver pain medicine directly where it's needed.

The study wants to understand which of these two pain relief methods — the epidural or the rectus sheath block — works best to help patients feel better and recover more quickly after their surgery. They will be looking at how well patients feel and their general recovery using a special questionnaire called the Quality of Recovery-15 score.

Key takeaways

Compares epidural vs. rectus sheath block for pain after major tummy surgery.
Aims to find the best pain relief for faster recovery.
Participation involves random assignment to one pain relief method.
Focuses on improving recovery, especially for cancer surgery.
You'll be asked about your pain and recovery after surgery.

Who may be eligible?

To be part of this study, you need to be an adult (18 years or older) who is scheduled for a specific type of major tummy operation called a midline laparotomy. It's important that you are able to understand and sign a consent form, showing you agree to take part, and that you can understand French. You also need to be part of a social security system.

There are several reasons why you might not be able to join. For example, if you have an allergy to certain pain medicines, or if you have specific heart, blood, or nerve conditions that make epidurals or rectus sheath blocks unsafe for you, you won't be able to participate. Also, if you're pregnant, deeply involved in another medical study, or in certain legal or psychiatric care situations, you won't be eligible. The hospital team will check all these details carefully to make sure the study is right and safe 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.

Am I 18 years old or older?
Am I scheduled for a midline laparotomy (major tummy surgery)?
Can I understand French and sign a consent form?
Do I have any allergies to local pain medicines?
Do I have any serious blood, nerve, or heart conditions?

Answer every question to see your result.

What does participation involve?

This study involves receiving one of two pain relief methods for your planned major tummy surgery. You won't get to choose which method you receive – it will be decided randomly, like flipping a coin. After your surgery, the research team will monitor your pain and recovery. At various times, you'll be asked to complete questionnaires, like the Quality of Recovery-15, to see how you're feeling and how well you're recovering. The pain relief will be managed as part of your standard care, but the research team will specifically track its effects. The total duration of your participation will cover your hospital stay and any follow-up assessments related to your pain relief and recovery.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a pain relief technique that could lead to a faster and more comfortable recovery after your surgery. For example, if the rectus sheath block is found to be as effective as an epidural but with fewer side effects, you might experience those advantages. However, as with any medical procedure, there are potential risks associated with both pain relief methods, which your anaesthetist will discuss with you. You are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (2)

CHR Metz Thionville Hopital de Mercy
Verified postcode
Metz, France· Recruiting
CHR Metz-Thionville Hopital Bel Air
Verified postcode
Thionville, France· Not yet recruiting

Common questions

What is a 'midline laparotomy'?

It's a major operation where a cut is made down the middle of your tummy to access organs inside. It's often done for serious conditions.

What is an epidural?

It's a common pain relief method where a thin tube is placed in your back to deliver medicine that numbs the area.

What is a 'rectus sheath block'?

It's a newer pain relief method where medicine is delivered through small tubes placed near the muscles in the front of your tummy.

Will I get to choose my pain relief method?

No, in this study, the pain relief method you receive will be chosen randomly, like by chance.

What does 'fast-track rehabilitation' mean?

It's a modern approach to surgery that aims to help you recover and get back to your normal activities as quickly and safely as possible.

How to find out more

Arpiné EL NAR, PhD

arpine.el-nar@chr-metz-thionville.fr 0033387557766 Official trial record

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