RecruitingOBSERVATIONAL

A Multicenter Patient Registry on Outcomes From Cryoanalgesia of the Intercostal Nerves

This study is gathering information about a treatment called cryoablation, also known as cryoanalgesia, which uses cold to numb nerves. Specifically, it's looking at how well this treatment helps people manage pain after surgery, particularly pain in the nerves between the ribs (intercostal nerves). Doctors are collecting details from patients who have had or will have this cooling treatment, as well as from similar patients who haven't had it. The main goal is to understand how effective this method is in reducing post-operative pain and improving patients' experiences. It’s an observational study, which means researchers are just watching and recording what happens.

At a glance

Status

Recruiting

Sponsor

AtriCure, Inc.

Enrolment target

5,000

Start

29 Jun 2018

Estimated completion

01 Jan 2040

Post Operative Pain

What is this study about?

Imagine you've had an operation, and you're dealing with pain afterwards. This study is all about understanding a special way to manage that pain, especially when it comes from the nerves between your ribs. It's called cryoanalgesia, which simply means using cold to relieve pain. Think of it like putting ice on a sprain, but for your nerves.

Doctors are collecting information from patients across different hospitals who have either had this cooling treatment on their intercostal nerves, or who are similar but haven't had the treatment. They want to see how well it works to reduce pain after surgery. By observing many patients, they hope to get a clear picture of the benefits and how people recover.

This isn't a study where new treatments are tested; instead, it's about carefully watching and recording what happens with treatments that are already in use. It helps doctors learn more about the real-world experiences of patients and how different pain management approaches compare.

Key takeaways

This study observes how a cooling treatment (cryoanalgesia) helps with pain after surgery.
It aims to learn if this treatment is effective for pain in the nerves between the ribs.
You won't get special treatment for the study; information is collected from your usual care.
It's about understanding real-world patient experiences.
Participation is voluntary and won't affect your medical care if you withdraw.

Who may be eligible?

To be considered for this study, you need to be at least 12 years old. You also need to be able to understand the study and agree to take part, following UK laws about consent.

The main requirement is that your doctor has scheduled you to have, or you've already had, the special cooling treatment on the nerves between your ribs. The study also includes similar patients who are managing their post-surgery pain without this specific cooling method, so they can compare the results.

There are a few reasons you might not be able to join. For example, if you're already in another study that might affect the treatment you receive, or if local hospital rules prevent it. Also, if you're a woman who could become pregnant and are currently pregnant, or planning a pregnancy during the study, you wouldn't be able to participate.

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 12 years old or older?
Have you been offered or had the 'cooling' pain treatment for nerves near your ribs?
Are you able to understand and agree to take part in the study?
Are you currently pregnant or planning to be during the study period?
Are you already in another medical study that might affect this one?

Answer every question to see your result.

What does participation involve?

This is an 'observational' study, which means doctors will mostly be collecting information from your ordinary medical care. You won't be given any new or experimental treatments just for the study. Instead, details about your pain levels, your recovery, and any treatments you receive will be recorded from your medical notes during your hospital stay and possibly during follow-up appointments. The exact number of visits and follow-ups will depend on your usual medical care and how long your doctor typically monitors your recovery. You won't be asked to take any study-specific medication or have extra tests beyond what your own doctor thinks is best for your care. The total duration of your participation will depend on how long the doctors want to follow your progress, which could be several months.

Potential risks and benefits

Participating in this study might help improve understanding of post-operative pain management for others in the future. For you personally, there may not be direct benefits as you'll be receiving standard care. As this is an observational study, the risks are generally low, as you're not undergoing any extra or experimental procedures. However, with any medical treatment, there's always a chance of side effects or complications, but these would be related to your general medical care rather than the study itself. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Baptist MD Anderson Cancer Center
Verified postcode
Jacksonville, United States· Recruiting
AdventHealth
Verified postcode
Orlando, United States· Recruiting
Luminis Health Anne Arundel Medical Center
Verified postcode
Annapolis, United States· Recruiting
St. Luke's Hospital of Kansas City
Verified postcode
Kansas City, United States· Completed
Elliot Hospital
Verified postcode
Manchester, United States· Recruiting
The Christ Hospital
Verified postcode
Cincinnati, United States· Recruiting
Baylor College of Medicine
Verified postcode
Houston, United States· Recruiting
Medical University of Vienna
Verified postcode
Vienna, Austria· Recruiting
UZ Leuven
Verified postcode
Leuven, Belgium· Recruiting
University of Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
University Hospitals Leicester NHS Trust
Verified postcode
Leicester, United Kingdom· Recruiting

Common questions

What is 'cryoanalgesia'?

It's a treatment that uses very cold temperatures to temporarily numb nerves, which can help to reduce pain.

Will I get this cooling treatment if I join the study?

No, whether you get the treatment or not is decided by your own doctor for your care. The study just records what happens.

Do I need to do anything extra if I join?

Mostly no. The researchers will gather information from your existing medical records and appointments. You won't usually have extra visits or tests just for the study.

Can I leave the study at any time?

Yes, absolutely. Your decision to participate is voluntary, and you can withdraw at any point without it affecting your medical treatment.

Will my personal details be kept private?

Yes, all information collected for the study will be handled carefully to protect your privacy and kept confidential.

How to find out more

Elizabeth Menard

reduce-registry@atricure.com 8327120715 Official trial record

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