RecruitingPHASE3INTERVENTIONAL

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

The LOLIPOP trial is a large international study looking into whether a medication called lidocaine, given into a vein during and up to 24 hours after breast cancer surgery, can help prevent long-lasting pain. We're also checking how safe it is. Researchers will compare lidocaine to a dummy treatment (placebo) in thousands of women undergoing breast cancer surgery for either a mastectomy or breast-conserving surgery. The main goal is to see if lidocaine reduces moderate or severe pain one year after surgery. We will also monitor pain scores, use of other pain medications, and overall quality of life.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Monash University

Enrolment target

4,300

Start

27 Jul 2022

Estimated completion

01 Jul 2028

Breast Cancer Breast Cancer Female Breast Conserving Surgery Mastectomy

What is this study about?

This study, called LOLIPOP, is investigating a common medication called lidocaine. You might have heard of lidocaine as a numbing cream or injection used by dentists. In this study, however, it's given directly into a vein during and for a short period after breast cancer surgery. The main aim is to find out if this treatment can help prevent moderate or severe long-lasting pain, sometimes called chronic post-surgical pain, which can affect some women a year after their breast cancer operation. This research is important because reducing pain after surgery can greatly improve a patient's recovery and quality of life.

To get clear and reliable results, the study is very large, involving 4,300 patients from different hospitals worldwide. Patients are randomly assigned to receive either lidocaine or a dummy treatment (placebo) without knowing which one they are getting. This helps ensure that any differences observed are truly due to the lidocaine and not other factors. Researchers will then check in with patients after one year to assess their pain levels and gather other information.

Beyond just pain, the study will also look at how safe the lidocaine infusion is, how much other pain relief patients need, and how their quality of life and psychological well-being are affected. By understanding this, we hope to improve care for women having breast cancer surgery in the future.

Key takeaways

This study is testing if lidocaine given into a vein can reduce long-term pain after breast cancer surgery.
It's a large international study comparing lidocaine to a dummy treatment.
Participation involves receiving medication during/after surgery and follow-up for one year.
The study includes women having a mastectomy or breast-conserving surgery for new breast cancer.
Your health team will decide if the study is suitable for you based on specific criteria.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for women aged 18 or over who are having surgery for breast cancer. This includes women having a full breast removal (mastectomy) or a smaller operation to remove just the cancer (breast-conserving surgery). You might be eligible if your surgery is to treat newly diagnosed breast cancer, including if you're also having breast implants or tissue expanders inserted at the same time.

There are several reasons why you might not be able to join. For example, if you've already had breast cancer surgery in the same area or if your surgery is for cancer that has come back. You also wouldn't be able to take part if you have ongoing pain at the site of the planned surgery, are planning complex reconstructive surgery soon after, or if you have certain heart conditions or have had a recent heart attack. People who are pregnant or breastfeeding, have severe memory problems, or a known allergy to lidocaine or similar medicines are also not suitable for this study.

It's important to remember that the study is specifically for women, and transgender patients are not eligible. The medical team will carefully review all your health information to see if this study is right 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 or older?
Are you undergoing a mastectomy or breast-conserving surgery for newly diagnosed breast cancer?
Do you have a pre-existing severe heart condition or a recent heart attack?
Are you pregnant or breastfeeding?
Do you have any known allergies to lidocaine or similar numbing medications?
Are you having surgery for cancer that has returned, rather than a new diagnosis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the LOLIPOP trial, you would receive either the study medication (lidocaine) or a dummy treatment (placebo) through an IV drip during your breast cancer surgery and for up to 24 hours afterwards. You won't know which one you're receiving. Over the following year, you'll have check-ups, which may include answering questions about your pain levels, any other pain relief you're using, and your general well-being. There will be at least one main assessment specifically to check for moderate or severe pain one year after your surgery. The total duration of your participation in the study will be at least one year.

Potential risks and benefits

Participating in this study might offer a potential benefit if lidocaine reduces your risk of developing long-term pain after surgery, or it could lead to better pain control short-term. However, there's also a chance you might receive the dummy treatment, meaning you won't get any active study drug. As with any medication, lidocaine can have side effects, and these will be carefully monitored. The study team will explain all potential risks and benefits in detail. Your involvement is completely voluntary, and you are free to withdraw from the study at any time without affecting your medical care.

Locations (47)

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

Nepean Hospital
Verified postcode
Kingswood, Australia· Recruiting
Blacktown Mount Druitt Hospital
Verified postcode
Mount Druitt, Australia· Recruiting
Royal North Shore Hospital
Verified postcode
Sydney, Australia· Recruiting
Westmead Hospital
Verified postcode
Sydney, Australia· Recruiting
St George Hospital
Verified postcode
Sydney, Australia· Recruiting
Royal Brisbane and Women's Hospital
Verified postcode
Brisbane, Australia· Recruiting
Queen Elizabeth II Jubilee Hospital
Verified postcode
Coopers Plains, Australia· Recruiting
Mackay Base Hospital
Verified postcode
Mackay, Australia· Recruiting
Rockhampton Hospital
Verified postcode
Rockhampton, Australia· Terminated
Gold Coast Hospital and Health Service- Gold Coast University Hospital
Verified postcode
Southport, Australia· Terminated
Princess Alexandra Hospital
Verified postcode
Woolloongabba, Australia· Recruiting
Flinders Medical Centre
Verified postcode
Bedford Park, Australia· Recruiting

Common questions

What is lidocaine?

Lidocaine is a common medication used to numb certain areas or, when given into a vein like in this study, it can also act as a pain reliever.

Why is this study important for breast cancer patients?

It aims to find out if using lidocaine during and after surgery can help prevent long-lasting pain, which can be a problem for some women after breast cancer operations.

Will I know if I'm getting lidocaine or the dummy treatment?

No, this is a 'blinded' study, meaning neither you nor your doctors will know whether you're receiving lidocaine or the dummy treatment until after the study is complete.

What kind of surgery do I need to be having to join?

You need to be having either a mastectomy (full breast removal) or breast-conserving surgery for newly diagnosed primary breast cancer.

What if I change my mind about participating?

You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

How to find out more

Gillian Ormond

gillian.ormond@monash.edu +610399030387 Official trial record

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