A randomized, Phase 4, double-blind, placebo-controlled, 6-arm crossover study to investigate the systemic effect of lidocaine and ropivacaine when used for Transversus Abdominis Plane (TAP) blocks on hyperalgesia and pain perception in healthy volunteers aged 18 to 64 years.
This study is investigating two common pain-numbing medications, lidocaine and ropivacaine, to understand how they affect pain. It's a Phase 4 study, meaning these medicines are already approved and widely used. We're looking at their effects when given as a 'Transversus Abdominis Plane (TAP) block', which is a way to numb pain in the tummy area. Healthy men, aged 18 and above, will be involved. The main goal is to see how these medicines reduce extra pain sensitivity (hyperalgesia) and how people feel pain, in general. We'll also check for any side effects and how much of the medicine is in the blood. This helps us understand their effects better for patients who need pain relief.
At a glance
What is this study about?
This study is a detailed look at two common medicines used for numbing pain: lidocaine and ropivacaine. You might have heard of lidocaine as a local anaesthetic, often used by dentists or to numb a small area before a procedure. Ropivacaine is similar and also used to block pain. Both are already approved and regularly used in healthcare, which is why this is called a 'Phase 4' study – it means we're learning more about how they work in real-world situations, rather than testing if they are safe for the first time.
The main purpose of this study is to understand how these medicines work in a specific way, particularly when given as something called a 'Transversus Abdominis Plane (TAP) block'. This is a method doctors use to numb the nerves in the abdominal (tummy) wall, often to help with pain after surgery. We want to see if these medicines reduce something called 'hyperalgesia', which is when you become extra sensitive to pain, and also how they affect your general feeling of pain.
To do this, healthy volunteers will experience very mild electrical stimulation, which helps us measure pain sensitivity. The study will also track things like how strongly pain is felt, how much pressure people can tolerate before it becomes painful, and how much of the medicine is in the blood. We'll also carefully watch for any side effects and check your blood pressure and heart rate. All this information helps doctors better understand how to use these medicines for effective pain relief.
Key takeaways
- Tests pain-numbing medicines (lidocaine, ropivacaine) for acute pain.
- Focuses on how these medicines affect pain sensitivity (hyperalgesia).
- Uses a 'TAP block' injection type, common for tummy pain relief.
- Healthy men aged 18+ can participate.
- Aims to improve understanding of pain relief for future patients.
Who may be eligible?
To be able to take part in this study, you need to be a healthy man aged 18 years or older. There is no upper age limit, so men of any adult age can be considered.
It's important that you are generally healthy. This means you shouldn't have any significant medical conditions that might affect how the medication works or how you respond to the study procedures.
The study is specifically looking for men, and healthy volunteers are needed. This helps researchers understand the basic effects of the medicines without other health problems complicating the results.
- Are you a man?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to commit to several study visits?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be part of a 'crossover' study. This means you will receive both of the active medicines (lidocaine and ropivacaine) and a 'placebo' (a salt water solution that looks like the medicine but has no active drug), at different times. You won't know which one you're getting each time, and neither will the study team.
Each time you participate in a session, you'll receive an injection of one of the study treatments as a TAP block. Over several visits, you'll have different tests. These include mild electrical stimulation to measure pain sensitivity, checks of how much pressure you can tolerate, and blood tests to measure the amount of medicine in your system. We will also monitor your blood pressure and heart rate, and ask you about any side effects you experience. Your participation will involve multiple visits over time, but the total duration of your involvement will be clearly explained by the study team.
Potential risks and benefits
Locations (1)
- —Norway
Common questions
What is a 'TAP block'?
A TAP block is a type of injection to numb the nerves in the muscle layers of your tummy area. It's often used to help manage pain, especially after surgery.
What is a 'placebo'?
A placebo is a substance that looks exactly like the real medicine but contains no active drug. It helps us compare the effects of the actual medicines properly.
Will I feel pain during the study?
The study involves mild electrical stimulation to measure pain sensitivity. This is carefully controlled and designed to be tolerable, not intensely painful. You'll also have pain-numbing medicines.
How long will each study visit last?
The exact duration of each visit will vary depending on the tests and monitoring needed. The study team will provide you with a detailed schedule and estimate of time for each session.
Will I get paid for taking part?
Information about compensation for time, travel, or expenses related to your participation will be discussed by the study team if you are considered for the study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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