AuthorisedTherapeutic use (Phase IV)Interventional

Effect of local 0.5% lidocaine injection in the prevention of acute postoperative pain associated with breast surgery

This research study is investigating if a common local anaesthetic called lidocaine, when injected locally during breast surgery, can help manage pain in the first couple of days after the operation. Many women experience acute pain after breast surgery, and finding effective ways to reduce this is very important. The study will look at how much pain women feel at different times (1, 4, 12, 24, and 48 hours) after their surgery, both when they are resting and when they move their arm. This is a Phase IV study, which means the treatment (lidocaine) is already approved and widely used, but researchers are now trying to understand more about its specific use in preventing post-operative pain in breast surgery patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Consorci Sanitari Integral

Enrolment target

128

Start

11 Feb 2025

Disminuir dolor en cirugía de mama

What is this study about?

This study is designed to see if giving a local anaesthetic injection of lidocaine during breast surgery can lessen the pain women feel afterwards. Many people experience pain after surgery, and the aim here is to find better ways to manage it, specifically during the first two days following breast surgery. Lidocaine is a medicine that numbs a small area of the body, and it's already used commonly in many medical procedures.

Researchers will be carefully checking how much pain women have at several points after their surgery – at 1, 4, 12, 24, and 48 hours. They will measure pain both when someone is resting and when they gently move their arm above their head (more than 90 degrees). This will help them understand if the lidocaine injection makes a noticeable difference to pain levels.

This type of study is called a 'Phase IV' study. This means that lidocaine is already a well-known and approved medicine. However, doctors are still learning about the best ways to use it for specific purposes, like preventing pain after breast surgery. The information gathered from this study could help doctors make better decisions about pain relief for women undergoing breast surgery in the future.

Key takeaways

The study aims to see if lidocaine injections reduce pain after breast surgery.
It focuses on pain levels in the first 48 hours post-surgery.
Lidocaine is a common local anaesthetic.
Participation involves receiving the injection and having pain levels monitored.
It's a Phase IV study, meaning lidocaine is already an approved medicine.
Only adult women having breast surgery can participate.

Who may be eligible?

To take part in this study, you would need to be an adult woman, at least 18 years old. There is no upper age limit specified, so older women can also be considered.

The study is specifically looking at women who are having breast surgery. Beyond being an adult woman undergoing this type of surgery, other specific health conditions or medications might affect whether you can join, but these details are not available here. The medical team would review your full health history to make sure the study is safe and suitable for you.

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?
Are you female?
Are you scheduled for breast surgery?
Do you understand that the study is testing a pain relief method, not a new surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive an injection of lidocaine around the area of your breast surgery as part of your normal surgical procedure. This is the main intervention being studied. After your surgery, the research team would monitor your pain levels carefully over the next 48 hours. This would likely involve regularly asking you about your pain using a simple scale while you are resting and when you do a gentle arm movement. There would be no extra hospital visits beyond your standard surgical care and recovery. The total duration of your active participation, for pain measurement, would be limited to the first two days after your surgery.

Potential risks and benefits

A potential benefit of taking part could be improved pain relief after your breast surgery, although this is what the study is trying to find out. Lidocaine is generally considered safe, but like all medicines, it can have side effects, such as temporary stinging at the injection site or, very rarely, allergic reactions or effects on the heart. You would be closely monitored by medical staff. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting the quality of 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
Spain

Common questions

What is lidocaine?

Lidocaine is a common medicine used to numb a specific area of your body and is often called a local anaesthetic.

What kind of surgery is this study for?

This study is specifically for women who are having breast surgery.

How will my pain be measured?

Your pain will be measured using a simple scale at different times after your surgery, both when resting and during specific arm movements.

Will I have extra doctor's appointments?

No, your participation for pain measurement will take place during your standard recovery time in the hospital, with no additional appointments.

Can I stop participating if I change my mind?

Yes, you are free to withdraw from the study at any time without it affecting your medical care.