Active not recruitingPHASE4INTERVENTIONAL

Local Anesthetic Response in Ehlers-Danlos Syndrome (EDS) and Healthy Volunteers

This study is investigating a common concern among people with Ehlers-Danlos Syndrome (EDS): that local anaesthetic, which is used to numb pain during procedures, might not work properly or wear off too quickly. Many EDS patients have reported this, but there isn't much scientific information to explain why. Researchers want to compare how local anaesthetic affects people with EDS versus healthy volunteers (people without EDS). They will use two types of injections: a salt water solution and a common numbing medicine called Lidocaine. The aim is to understand if the anaesthetic doesn't work at all, or if it just doesn't last long enough, to help doctors give better care during dental work or minor operations.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

University of Calgary

Enrolment target

155

Start

10 Nov 2022

Estimated completion

01 Jun 2027

Ehlers-Danlos Syndrome Anesthesia, Local

What is this study about?

Many patients with Ehlers-Danlos Syndrome (EDS) have shared that when they get local anaesthetic – the pain-numbing medicine dentists and doctors use – it often doesn't work as well or doesn't last for as long as it should. This can be really worrying when you're facing a procedure like a dental filling or a minor operation. While lots of people with EDS have experienced this, there hasn't been much scientific research to properly understand why this happens.

This study is designed to carefully look into this problem. Researchers want to find out exactly how often local anaesthetic issues occur in people with EDS compared to people who don't have EDS. They also want to understand if the problem is that the numbing medicine simply doesn't work from the start, or if it works but wears off much quicker than expected. By gathering this clear, objective information, they hope to get a better picture of what's really going on.

The findings from this study could be very important. If doctors have a clearer understanding of how local anaesthetics affect people with EDS, they can adjust treatments to make sure patients are comfortable and pain-free during medical and dental procedures. This could lead to better care and a less stressful experience for people living with EDS.

Key takeaways

Many people with EDS report issues with local anaesthetic.
This study aims to get clear facts on why anaesthetic might not work for EDS patients.
It compares responses in people with EDS and healthy volunteers.
The findings could help improve pain relief for EDS patients during procedures.
Participation involves receiving two common injections for observation.

Who may be eligible?

To join this study, you need to be at least 18 years old. The study is open to people of all genders.

There are two main groups of people they are looking for: those with Ehlers-Danlos Syndrome (EDS) and healthy volunteers (people who don't have EDS). If you have EDS, you need to have a clear diagnosis of hypermobile EDS based on the 2017 guidelines, or a genetically confirmed diagnosis of another type of EDS (not hypermobile).

However, you cannot take part if you are allergic to Lidocaine, which is a common numbing medicine that will be used in the study. You also need to be able to understand what the study involves and agree 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?
Do you have a firm diagnosis of Ehlers-Danlos Syndrome?
Or are you a healthy person without EDS?
Are you NOT allergic to Lidocaine?
Are you able to understand the study and agree to take part?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive two types of injections. One injection will be a simple salt water solution (which won't numb you), and the other will be Lidocaine, a common numbing medicine. The purpose is to compare how each affects you. The study will last for a short period, likely during a single visit, as they observe your response to these injections. The study aims to complete data originally gathered at an EDS conference in 2019, so it likely involves straightforward observation after the injections.

Potential risks and benefits

Participating in this study won't directly improve your health, but it could help doctors better understand how local anaesthetics affect people with EDS, which might lead to better care for others in the future. The main risk involves receiving injections, which can cause minor discomfort, bruising, or swelling. If you are allergic to Lidocaine, you would not be able to join. Remember, taking part is completely voluntary, and you can withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (1)

Cardiovascular Autonomic Research Lab, University of Calgary
Verified postcode
Calgary, Canada

Common questions

What is local anaesthetic?

It's a medicine used to numb a small area of your body so you don't feel pain during minor procedures, like at the dentist.

What is Ehlers-Danlos Syndrome (EDS)?

EDS is a group of conditions that affect the body's connective tissues, which support skin, bones, blood vessels, and many other organs.

Why is this study important for people with EDS?

It aims to understand why local anaesthetic might not work well for people with EDS, which could lead to better pain management during medical procedures.

Will I get any specific treatment in this study?

No, this study is about observing how you react to common injections, not about giving new treatments.

How long will my participation last?

The study aims to observe your reaction to injections, likely during a single visit or a short period.