RecruitingPHASE3INTERVENTIONAL

Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.

This study is comparing two different approaches to pain relief during and after breast reconstruction surgery for breast cancer. One group of patients will receive standard pain relief that includes strong medications called opioids. The other group will receive an approach that aims to reduce the need for opioids. Researchers want to see if this second approach leads to patients needing less strong pain medication (like morphine) in the first two days after surgery. This is a Phase 3 study, meaning it's a later stage trial looking closely at the effectiveness and safety of the new approach in a larger group of people. The goal is to find the best and safest ways to manage pain for these surgeries.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Institut Curie

Enrolment target

158

Start

07 Dec 2022

Estimated completion

06 Jun 2027

Breast Cancer

What is this study about?

This study is looking at one specific type of surgery called breast reconstruction, which often happens for women who have had breast cancer. The main idea behind this research is to compare two different ways of managing pain during and immediately after the surgery.

One group of patients will have their pain managed with the usual methods, which include strong pain medications known as opioids. The other group will be given a different combination of medicines during their anaesthetic, with the aim of reducing the need for these strong opioid painkillers. The researchers want to see if this new approach helps patients feel comfortable after surgery while needing less morphine or similar strong painkillers in the first two days. This could be important because opioids can sometimes have side effects, and finding ways to use less of them while still managing pain effectively would be a step forward.

This is a 'Phase 3' study, which means it’s a detailed and thorough investigation. It's being carried out in several hospitals (multicentric) and patients are randomly assigned to one of the two groups, like flipping a coin. This helps make sure the results are fair and reliable. The long-term goal is to improve how pain is managed for patients undergoing breast reconstruction, making their recovery as smooth and comfortable as possible.

Key takeaways

Compares two pain relief methods for breast reconstruction surgery.
One method tries to reduce the use of strong opioid painkillers.
Focuses on pain relief needed in the first 48 hours after surgery.
Aims to improve pain management for breast reconstruction patients.
Open to women aged 18+ having this specific surgery in France.

Who may be eligible?

To join this study, you need to be a woman aged 18 or older and living in France, with French health insurance. You must be planning to have breast reconstruction surgery using a 'free flap' technique under general anaesthetic. If you're able to become pregnant, you'll also need a negative pregnancy test.

There are several reasons why you might not be able to join. These include having an allergy to any of the specific medications used in the study (such as dexmedetomidine, remifentanil, or morphine), or if you have certain existing health conditions like severe heart problems, serious kidney issues, very low blood pressure, severe asthma, or an active stomach ulcer. If your pulse is very slow, or you're taking certain heart medications, you might also not be eligible.

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 aged 18 or older?
Do you have French health insurance?
Are you having breast reconstruction (free flap) surgery?
Do you have any severe heart, kidney, or lung conditions?
Do you have any known allergies to the listed study medications?
Are you currently taking certain blood pressure medications (ACEI/ARB)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups – meaning it's decided by chance which pain management approach you receive. You'll undergo your breast reconstruction surgery as planned. After your surgery, the research team will closely monitor your pain levels and how much pain relief you're needing, especially in the first 48 hours. They'll also record any side effects you experience. Your participation will mainly involve the period around your surgery and immediate recovery, and the total duration would be until 48 hours post-surgery for the main recording of morphine consumption.

Potential risks and benefits

Potential benefits of taking part could include receiving an anaesthetic approach that might lead to less need for strong opioid painkillers after surgery, which could reduce side effects sometimes associated with these medications. Both approaches aim to manage your pain effectively. As with any medical procedure or trial, there are potential risks, primarily related to side effects from the medications used, though these are carefully considered for patient safety. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual hospital care.

Locations (3)

Institut Curie Paris
Verified postcode
Paris, France· Recruiting
Institut Curie Saint-Cloud
Verified postcode
Saint-Cloud, France· Recruiting
Gustave Roussy, Cancer Campus, Grand Paris
Verified postcode
Villejuif, France· Recruiting

Common questions

What is a 'free flap' breast reconstruction?

This is a type of breast reconstruction where tissue (like skin, fat, and sometimes muscle) is taken from another part of your body and moved to your chest to create a new breast shape.

What are opioids?

Opioids are strong pain-relieving medications prescribed for moderate to severe pain. Examples include morphine. While very effective, they can have side effects like sickness and constipation.

Will I still get pain relief if I'm in the 'opioid-free' group?

Absolutely. The aim is to manage your pain effectively using a different combination of medications, not to leave you in pain. The study is comparing different pain management strategies.

Is this a new medicine being tested?

The study isn't testing a brand new medicine that's never been used before. Instead, it's comparing different ways of combining well-known medications (like dexmedetomidine and other pain relief medicines) during surgery to see which approach works best for pain control afterwards.

How will my pain be measured?

Your pain will likely be measured using a simple scale where you rate your pain level, often from 0 (no pain) to 10 (worst possible pain). Nurses and doctors will ask you about your pain regularly.

How to find out more

Anne-Claire COYNE, PhD

anne-claire.coyne@curie.fr 0033156245765 Official trial record

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