RecruitingNAINTERVENTIONAL

Rotator Cuff Repair Under Isolated Loco-regional Anesthesia

This study is about people having surgery for a rotator cuff tear, which is a common shoulder injury causing pain and weakness. Normally, this surgery uses a combination of general anaesthesia (being fully asleep) and local numbing medicine in the shoulder area. This local numbing helps with pain after the operation. However, some surgeons are now doing the surgery with just the local numbing medicine, meaning the patient stays awake. This study aims to compare specific things, like blood pressure during the operation, between these two different approaches to anaesthesia. The researchers want to understand if having just the local numbing medicine is a safe and effective option, especially considering past issues with shortages of general anaesthesia drugs.

At a glance

Status

Recruiting

Phase

Sponsor

Elsan

Enrolment target

Start

13 Nov 2023

Estimated completion

01 Jul 2025

Shoulder Cuff Surgical Repair

What is this study about?

If you've hurt your shoulder, you might have a problem called a rotator cuff tear. This causes pain and makes your arm feel weak. Sometimes, surgery is the best way to fix it. Usually, this surgery involves not only being completely asleep (general anaesthesia) but also getting a special injection that numbs your shoulder specifically. This numbing injection is great because it helps keep the pain away for several hours after your surgery.

Now, some doctors are doing this shoulder surgery using only the numbing injection, which means the patient stays awake during the procedure. This is sometimes called "loco-regional anaesthesia." There's an idea that this approach might keep your blood pressure more stable during the operation. Also, during the COVID-19 pandemic, there were shortages of the medicines needed for general anaesthesia, which sometimes meant people couldn't get their surgery when they needed it. This study is important because it's looking into how these two different ways of managing pain during surgery affect your blood pressure. The goal is to compare what happens with blood pressure when patients are either fully asleep with a local numb, or awake with just the local numb.

The results of this study could help doctors decide the best and safest way to give anaesthesia for shoulder surgery in the future. It could also show if having surgery with only local numbing is a good and reliable option that might avoid some of the medicines used in general anaesthesia.

Key takeaways

This study compares two types of anaesthesia for shoulder surgery.
It examines if local numbing alone is as good as local numbing plus general anaesthesia.
The main focus is on how blood pressure changes during surgery.
Participation involves being randomly assigned to one of the two anaesthesia groups.
The goal is to improve future care for people needing shoulder surgery.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. You must have a specific type of tear in your shoulder (rotator cuff tear) that your doctor says needs surgery. This tear shouldn't be too severe or have too much fat in the muscle, as confirmed by your doctor. You also need to be part of a social security system and agree to take part after understanding everything about the study.

You cannot join if you've had shoulder surgery on the same shoulder before, or if your shoulder has severe arthritis. If your surgery involves repairing another part of the shoulder called the subscapularis, you're also not eligible. You also can't take part if you have medical reasons why you can't have either the local numbing medicine or general anaesthesia. If you've been known to faint easily, get very anxious, or are taking part in another medical study, this one isn't for you. Also, if you're pregnant, breastfeeding, or under legal protection, you can't join this study.

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?
Do you need surgery for a rotator cuff tear that isn't too severe?
Have you *not* had surgery on that shoulder before?
Are you *not* pregnant or breastfeeding?
Are you *not* currently in another medical research study?
Do you *not* have severe arthritis in your shoulder?

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. One group will have their shoulder surgery with local numbing medicine only (meaning you'll be awake). The other group will have local numbing medicine combined with general anaesthesia (meaning you'll be asleep). During the surgery, the research team will carefully monitor your blood pressure. After the surgery, you'll have standard follow-up care as you usually would for this type of operation. The doctors will also keep an eye on how well your shoulder recovers and how your pain is managed. The total duration of your participation will depend on the normal follow-up for your surgery.

Potential risks and benefits

Potential benefits of participating include helping doctors learn more about the safest and most effective way to provide anaesthesia for shoulder surgery, which could improve care for future patients. While both anaesthesia methods are commonly used, there are always potential risks with any medical procedure, including anaesthesia. These will be fully explained by your medical team. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (4)

Clinique Bretéché
Verified postcode
Nantes, France· Recruiting
CHP St Grégoire
Verified postcode
Saint-Grégoire, France· Not yet recruiting
Clinique Belledonne
Verified postcode
Saint-Martin-d'Hères, France· Recruiting
Hôpital privé St Claude
Verified postcode
Saint-Quentin, France· Recruiting

Common questions

What is a rotator cuff tear?

It's an injury to the tendons in your shoulder that help you lift and rotate your arm, often causing pain and weakness.

What is 'loco-regional anaesthesia'?

It's a type of numbing medicine given directly to the nerves around your shoulder, so you don't feel pain in that area but can stay awake.

Will I be awake during the surgery if I have only local numbing?

Yes, if you're in the group that receives only the local numbing medicine, you will be awake during the operation.

Why are they studying blood pressure specifically?

The study aims to see if one type of anaesthesia keeps your blood pressure more stable during surgery compared to the other.

Can I choose which type of anaesthesia I get?

No, if you're in the study, which type of anaesthesia you receive will be decided randomly, like drawing lots.

How to find out more

Vincent WYART, MSc

vincent.wyart@elsan.care 0240958176 Official trial record

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