RecruitingNAINTERVENTIONAL

Postoperative Analgesia Intervention With Non-opioid Alternatives (PAIN-Alt) Trial - Breast Surgery

This study, called PAIN-Alt, is exploring better ways to manage pain after breast surgery. In some parts of the world, like North America, doctors often prescribe strong opioid painkillers after surgery. However, these drugs can lead to addiction or be misused by others. This study wants to see if pain can be managed just as well using only non-opioid medicines, like those commonly used in other countries. We'll compare two groups: one receiving opioids and one receiving only non-opioid pain relief. We will look at how well pain is controlled, side effects, and how pain affects daily life. The goal is to help doctors make better decisions about pain relief after breast surgery and reduce the risks associated with opioid use.

At a glance

Status

Recruiting

Phase

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

540

Start

26 Nov 2024

Estimated completion

28 Feb 2026

Post Operative Pain Opioid Analgesic Adverse Reaction Surgery Postoperative Pain Breast Disease

What is this study about?

This study, called the PAIN-Alt Trial, is investigating whether pain after breast surgery can be managed effectively without using strong opioid painkillers. Opioids are medicines that can be very helpful for severe pain, but they also carry a risk of addiction and can have unpleasant side effects. In places like North America, it's common for doctors to prescribe opioids after surgery, even for procedures where patients go home the same day.

However, in many other countries, doctors successfully manage pain after breast surgery using only non-opioid medications. This trial aims to compare these two approaches: one group of patients will receive a pain relief plan that includes opioids, and another group will receive a pain relief plan that uses only non-opioid medications. The main goal is to find out if both approaches offer similar levels of pain relief and impact on daily life, while also looking at any side effects.

By understanding this better, doctors can make more informed choices about managing pain after breast surgery. If we find that pain can be managed just as well without opioids, it could significantly reduce the number of people who are exposed to the risks of these strong medications, including the potential for addiction or misuse.

Key takeaways

The study compares pain relief after breast surgery with or without strong opioid painkillers.
It aims to find out if non-opioid pain relief is as good as opioid pain relief.
Participation involves being assigned to a specific pain management plan and reporting your pain.
The goal is to improve pain treatment and reduce risks associated with opioid use.
You must be having breast surgery and plan to go home the same day.

Who may be eligible?

You might be able to join this study if you are an adult aged 18 or older and are having breast surgery (either a lumpectomy or mastectomy) for cancer or other breast conditions. You must also be planning to go home on the same day as your operation.

However, there are reasons you might not be able to join. For example, if your breast surgery includes immediate breast reconstruction (like implants or tissue flaps), as these procedures often cause more pain and require different pain management. Also, if you already take opioids regularly before your surgery, or if you have certain health conditions like heart failure, severe kidney or liver problems, bleeding disorders, or stomach ulcers, you might not be suitable.

Women who are pregnant or breastfeeding, or anyone with allergies to the study medications, also cannot take part. Finally, if you have difficulty understanding or remembering information, which would make it hard to answer questions about your pain, or if it's decided before your surgery that you'll need to stay in the hospital overnight, you wouldn't be able to participate.

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 having a lumpectomy or mastectomy for breast disease?
Are you planning to go home on the same day as your surgery?
Are you NOT having immediate breast reconstruction?
Are you NOT regularly taking opioids before your surgery?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be randomly assigned to one of two groups. One group will receive a pain management plan that includes opioid painkillers, and the other group will receive a plan with only non-opioid medications after your breast surgery. Your doctors will monitor your pain and provide the appropriate medication based on your assigned group.

You will be asked to report on your pain levels, how pain affects your daily activities, and any side effects you experience. This will likely involve answering questions or completing short forms at different times after your surgery. The full duration of your participation will depend on the study design, but generally, it involves tracking your recovery and pain management in the days and weeks following your operation. You will attend regular follow-up appointments, which may be in person or by phone, to assess your progress and collect information.

Potential risks and benefits

Participating in this study might offer the benefit of receiving carefully monitored pain relief tailored to your needs, and you'll be contributing to important research that could improve pain management for many others in the future. There are potential risks associated with any medication, including side effects from both opioid and non-opioid drugs. Opioids, while effective for pain, carry risks like nausea, constipation, and a small chance of dependence or addiction. Non-opioids also have their own potential side effects. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

McGill University Health Centre (Glen Site)
Verified postcode
Montreal, Canada· Recruiting

Common questions

What kind of breast surgery is included?

This study includes different types of breast surgery, such as a lumpectomy (removing a lump) or a mastectomy (removing part or all of the breast).

Will I still get pain relief if I don't get opioids?

Yes, you will still receive pain relief. This study is testing if non-opioid medications can be just as effective as those that include opioids.

What are non-opioid pain medications?

Non-opioid pain medications are common painkillers like ibuprofen, paracetamol (acetaminophen), or other medications that don't belong to the opioid family.

Why aren't people with breast reconstruction allowed in the study?

Breast reconstruction often causes more pain and requires different pain management strategies, so for this study, they are focusing on surgeries without reconstruction to keep the study results clearer.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any point, and your medical care will not be affected.

How to find out more

Samin Shirzadi, MD, MPH

samin.shirzadi@rimuhc.ca 6475643377 Official trial record

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