A study looking at passive movement during breast reconstruction surgery

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Breast cancer

Status:

Closed

Phase:

Other

This study is looking at the effects of gently moving a woman’s arms and legs during a breast reconstruction operation to see if it helps to reduce pain after surgery.

After a long car or plane journey you may feel stiff and uncomfortable with aches and pains in your back, arms or legs. If you have a long operation, you may have similar pain to this. The pain isn’t permanent but can last for several days.

Researchers would like to know if gently moving a patient’s arms or legs during surgery will reduce this pain and help them recover more quickly. A team of physiotherapists Open a glossary item have put together a set of gentle arm and leg movements that can be carried out while someone is under a general anaesthetic . Having someone move your arms or legs when you can’t is called passive movement.

The study team will recruit women with breast cancer who have already had surgery to remove their breast (a mastectomy), and are now having surgery to make a new breast shape (a breast reconstruction). Half the women taking part will have passive movement during their surgery. This won’t affect their surgery in any way.

The aim of the study is to see if passive movement during a long operation can reduce pain and improve recovery. You may not have any benefit from taking part in this study. But information from this study may be used to help people having surgery in the future.

Who can enter

You may be able to enter this study if you are female and

You have breast cancer
You have already had surgery to remove your breast (a mastectomy)
You are due to have surgery to make a new breast shape
The surgery you are having to make your new breast shape uses tissue taken from your tummy, and is either called a DIEP reconstruction or a TRAM free flap reconstruction
You are fit and healthy, and able to carry out your normal day to day activities
You are between 18 and 65 years old

You cannot enter this study if you are

Taking regular painkillers for long term pain
Allergic to any of the painkillers or the anaesthetic drugs used to put you to sleep for your surgery – you can ask your doctor about this

Trial design

This randomised study will recruit 142 women into 2 groups. Neither you nor your doctor can decide which group you are in. And neither of you will know which group you are in.

If you are in group 1 you will have 2 sets of passive movement during your surgery - once during a natural break in your surgery and once before you are taken to the recovery ward. Each set of passive movement will last 5 minutes.

If you are in group 2 you will have surgery as normal without any passive movement.

The study team will compare how well women in each group recover after surgery. During the first 5 days after your operation, they will ask you about any pain you might have and give you medication to treat this. They will also look at other parts of your recovery such as how well you can walk or do things for yourself.

You fill out a short questionnaire on the 1st, 3rd and 5th day, asking about any side effects and how you have been feeling. These are called quality of life studies. The questionnaire will take about 10 minutes to complete, and a researcher will help you if you wish. If you leave hospital on day 4, the researcher will call you on day 5 and complete the questionnaire with you over the phone.

If you have any problems with your new breast and need further surgery, you will not be able to carry on in the study. But the team will use the information they collected up until that point.