“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”
A trial looking at an extra type of pain control after surgery to remove your breast (SUBLIME)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at giving continuous local anaesthetic directly to where you had surgery to remove your breast (mastectomy). This is as well as the morphine pain relief you would usually have in this situation.
If you have a mastectomy to treat or try to prevent breast cancer, the most common problems you may have afterwards are long term pain and difficulty moving your shoulder on the side you had surgery. As well as being uncomfortable, these side effects can delay how quickly you get back to normal life.
Doctors want to reduce these possible long term problems. In this trial, they are testing an extra method of pain relief, alongside the morphine you would normally have. This method uses a small device for the first 24 hours after your operation, which delivers
The researchers believe this may work better than current pain relief methods in women who have had a mastectomy. And have fewer side effects. If you can be made more comfortable after surgery, and your arm movements get back to normal more quickly, this may also reduce longer term problems such as shoulder stiffness or pain. Half the women taking part in this trial will have this local anaesthetic, and the other half will have a dummy drug (placebo).
The aim of this trial is to see whether local anaesthetic delivered directly to where you had your surgery can improve pain control after surgery, as well as quality of life.
Who can enter
This trial is currently recruiting women being cared for at the Royal Cornwall Hospitals NHS Trust. If you are suitable for this trial, a member of the research team will ask if you would like to take part. Women taking part will be
- Due to have one of their breasts removed with surgery, either to treat cancer or try to prevent it
- At least 18 years old
You cannot enter this trial if you
- Have already had surgery to rebuild your breast
- Have dangerously low blood pressure for any reason
- Are sensitive or allergic to local anaesthetic, morphine, paracetamol or the anti sickness drug ondansetron
- Take a type of pain killing drug called an
opioidevery day, such as codeine or morphine
- Would not be able to use a patient controlled analgesia (PCA) pump, which helps you control pain
- Would not be able to complete a pain score chart for any reason
- Are taking part in another trial or study that may affect what the researchers are looking at
- Are pregnant
This trial will recruit 160 women. It is randomised. The women taking part will be put into one of 2 groups by a computer. Neither you nor your doctor will be able to decide or know the group you are in. This is called a double blind trial.
Before your surgery, the team will check how well you can move your arm on the side you are due to have your surgery.
Everyone taking part will have morphine pain relief through a drip into a vein. This is controlled by a patient controlled analgesia (PCA) pump. At the end of their surgery, everyone will also have a fine tube put under the muscles where their breast was. This tube runs a short distance under the skin from your wound to a small plastic device which is about the size of a tangerine.
If you are in group 1, the device will give you local anaesthetic through this tube for 24 hours after your surgery. The device will clip to your clothes, so you can move around with it.
If you are in group 2, the device will give you a dummy drug (placebo) for 24 hours after your surgery.
During these 24 hours you will fill out a pain score booklet. After the 24 hours is up, a nurse or doctor will gently remove the tube from your chest. This procedure is quick, and shouldn’t be painful. The team will also check again how well you can move your arm on the side you had your surgery.
The team will ask you to fill out some questionnaires before your surgery and 3 more times over the next 6 months. The questionnaires will ask about your general health and how well your shoulder on the affected side is working.
They will also ask permission to check your medical notes in about 5 years time to see how you are getting on. And, find out if there have been any longer term effects from the local anaesthetic pain relief method.
You see the trial team when you come to hospital for your routine appointments for your breast surgery. The trial appointments will take about 20 minutes each time.
Side effects or complications from having the tube put under the muscle where your breast was can include
- Having a tiny hole where the tube went in – this should almost disappear when healed
- Risk that the tube may fall out – this would not cause any harm
- The tube getting bent when it is removed, making the procedure a little more difficult
These are not common, and rarely cause major complications.
Very rare side effects of the local anaesthetic include
- Tingling in the area
- Abnormal heart rythmns
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Roger Langford
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
Peninsula Clinical Trials Unit at Plymouth University
Royal Cornwall Hospitals NHS Trust