AuthorisedTherapeutic confirmatory (Phase III)Interventional

APECS II: Comparing the efficacy of Pectoral Nerve (PECS II) Block with long-acting liposomal bupivacaine versus levobupivacaine for Mastectomy Surgery: A Multicenter Prospective Randomized Controlled Trial

This study, called APECS II, is for women having breast cancer surgery (mastectomy). It's looking at two different pain relief injections given during the operation to help with pain afterwards. One injection is a new, longer-lasting pain medicine, and the other is a more standard pain medicine. Researchers want to compare which one is better at controlling pain in the breast right after surgery. They will also look at how much other pain medication is needed, how quickly patients recover, and if they develop long-term pain. The goal is to find the best way to help patients have less pain after mastectomy and improve their recovery.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

St. Antonius Ziekenhuis

Enrolment target

130

Start

18 Jun 2024

Postoperative and chronic pain after breast cancer surgery

What is this study about?

When you have surgery, especially for breast cancer, managing pain afterwards is really important. This study is all about finding the best way to do that for women having a mastectomy, which is surgery to remove a breast.

Doctors are comparing two different types of pain relief. Both are given as an injection during the surgery to numb the area. One is a newer medicine that's designed to release slowly over time, potentially giving you pain relief for longer. The other is a more standard pain relief medicine. By comparing these two, doctors hope to learn which one is more effective at reducing pain in the breast after the operation.

The main aim is to see how much pain people report in their breast. But they will also look at other things, like how much extra pain medication you might need, how quickly you can leave the recovery room and go home, and if you develop any long-term pain. They also want to know if one method leads to better patient satisfaction and fewer side effects like sickness. This research could help doctors make better choices about pain relief for future patients.

Key takeaways

Aims to improve pain relief after breast cancer surgery (mastectomy).
Compares two types of pain relief injections given during surgery.
Will assess pain levels, need for other painkillers, and recovery time.
Goal is to find the most effective and safest pain management approach.
Participation involves routine monitoring of pain and recovery after surgery.

Who may be eligible?

This study is open to women who are 18 years old or older. You would be considered for this study if you are planning to have breast cancer surgery called a mastectomy.

It's important to remember that this study is specifically looking at pain relief for mastectomy. If you're having a different type of surgery, or if you don't meet the age requirement, this study wouldn't be suitable for you.

Your doctors will be able to check all the specific details to see if this study is a good fit for your individual situation.

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 a woman?
Are you 18 years old or older?
Are you scheduled for a mastectomy (breast removal surgery)?
Have you discussed your breast cancer treatment with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive one of the two pain relief injections during your mastectomy surgery. This means neither you nor your doctor would choose which injection you get – it's like flipping a coin to ensure a fair comparison.

After your surgery, doctors and nurses will regularly ask you about your pain levels, especially in your breast, using a simple pain scale. They will also keep track of any other pain medications you need. You might fill out questionnaires about your satisfaction and recovery. They will monitor how long you stay in the recovery room and when you are ready to go home. There will also be a follow-up to check if you experience any long-term pain more than 12 weeks after surgery. The total duration of your participation, including follow-up, will involve several checks after your surgery.

Potential risks and benefits

Potential benefits of taking part could include receiving an improved pain relief treatment, which might lead to less pain and a more comfortable recovery after your surgery. However, there's no guarantee that participating will personally benefit you. Potential risks are generally low, as both pain relief medicines are commonly used. Side effects could include those typically associated with pain relief injections, such as mild discomfort at the injection site or, very rarely, more serious issues that your doctor would discuss with you. You have the right to withdraw from 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
Netherlands

Common questions

What kind of surgery is this study for?

This study is specifically for women having a mastectomy, which is surgery to remove a breast, often due to breast cancer.

What are they testing in this study?

They are comparing two different pain relief injections given during surgery to see which one works best to reduce pain after a mastectomy.

Will I get to choose my pain medicine?

No, if you join, you'll be randomly assigned to receive one of the two medicines, just like choosing by chance. Neither you nor your doctor will decide.

What will I have to do if I join?

You'll have your surgery as planned. Afterwards, you'll be asked about your pain levels and recovery, and medical staff will monitor your progress.

Can I stop being part of the study at any time?

Yes, you can decide to leave the study at any point, and your decision won't affect your medical care.