Ongoing, recruitingTherapeutic use (Phase IV)Interventional

The Intertransverse Process Block - Single or Multiple Injection? A randomised, procedure related, blinded crossover trial in healthy volunteers

This research study is investigating a type of pain relief method called an 'Intertransverse Process Block' (ITP block). This method is often used to help manage pain, particularly after breast cancer surgery. The study involves healthy male volunteers and aims to find out if giving one injection or several injections works best to numb a particular area of the chest. Researchers will be looking at how many areas of the skin become numb and how long this numbness lasts. They will also be checking changes in skin temperature and blood pressure, as well as participants' satisfaction with the block. This helps scientists understand how to make pain relief as effective and comfortable as possible for patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Zealand University Hospital

Enrolment target

Start

24 Jan 2023

The ITP block is primarily used for pain amelioration after breast cancer surgery.

What is this study about?

Imagine you need an injection to help with pain, especially after an operation. This study is all about finding the best way to give one of those injections, specifically a type called an 'Intertransverse Process Block' (don't worry too much about the name!). This block helps numb parts of the chest, which is really useful for pain relief, for example, for people recovering from breast cancer surgery.

The main goal of this research is to see if giving just one injection of the pain-relieving medicine works better, or if giving several smaller injections is more effective. To do this, researchers will carefully measure how many areas of the chest skin become numb and for how long. This helps them understand how widely the pain relief spreads and how long it lasts.

Besides looking at how much skin gets numb, the study will also check other things. This includes measuring skin temperature changes, keeping an eye on blood pressure, and asking participants how satisfied they feel with the pain block. All this information helps doctors learn the best way to provide pain relief for patients in the future, making the treatment as good as it can be.

Key takeaways

Researchers are comparing single vs. multiple injections for pain relief.
The study aims to improve pain relief after surgeries like breast cancer surgery.
It involves healthy male volunteers.
Key measures include how much skin gets numb and for how long.
You would receive standard pain medications (Ropivacaine, Alfentanil).

Who may be eligible?

This study is looking for healthy men to take part. To be eligible, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate as long as they are healthy.

It's important to note that this specific study is only open to men. If you are a woman, you would not be able to join this particular research trial. The researchers are studying a very specific aspect of this pain relief, and for this part of their work, they are focusing on male volunteers.

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 male?
Are you at least 18 years old?
Are you generally in good health?
Are you willing to receive injections for pain relief?
Can you attend clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be helping researchers understand more about this pain relief method. Here's a general idea of what that might involve:

You would attend a research clinic for a visit. During this visit, you would receive the Intertransverse Process Block, which involves injections of pain-relieving medicines like Ropivacaine and Alfentanil. The study is designed so you might receive either a single injection or multiple injections, and you wouldn't know which one you're getting at the time, to keep the results fair.

After the injection, researchers would carefully check how many areas of your chest become numb. They would also take measurements of your skin temperature and blood pressure. You would be asked how satisfied you are with the block using a simple scale. Since this is a 'crossover' study, you might have a second visit after a period of time, where you would receive the other type of injection (if you had a single injection first, you'd get multiple ones next, and vice versa). The total duration of your participation would involve these visits and follow-up assessments.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is contributing to medical knowledge that could improve pain relief for patients in the future, especially those recovering from surgery. The medicines used are standard for pain relief, but as with any injection, there's a small risk of discomfort, bruising, or a reaction at the injection site. More serious, though rare, risks could include temporary nerve irritation. You will be closely monitored by medical staff throughout the study. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is an Intertransverse Process Block?

It's a type of injection to numb a specific area, usually in the chest, to help with pain relief after operations like breast cancer surgery.

Why are you only studying men?

For this stage of the research, the scientists are focusing on healthy male volunteers to understand specific aspects of how the block works.

What medicines will be used?

The study uses standard pain relief medicines called Ropivacaine and Alfentanil.

Will I feel pain during the study?

The purpose of the block is to numb areas. While there might be a brief sting from the injection, the goal is pain relief, and your comfort will be monitored.

What does 'crossover trial' mean?

It means you might try both methods being tested (single injection and multiple injections) at different times, so researchers can compare them in the same person.