SUBpectoral Local anaesthetic Infusion following MastEctomy:SUBLIME v1

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy.

• IRAS ID

  90502

• Contact name

  Roger Langford

• Sponsor organisation

  Royal Cornwall Hospital

• Eudract number

  2011-005775-16

• Research summary

  Breast cancer affects 1 in 9 women, many of whom require removal of the breast (mastectomy). Pain relief following surgery can be problematic. Some surgeons use local anaesthetic to try to ??numb?? the area and most use strong painkillers such as morphine directly into the bloodstream. Although a good painkiller, morphine has many side-effects. It is possible that poor pain relief may lead to patients experiencing long-term pain and reduced arm movement, affecting their ability to return to their usual daily activities. In Cornwall we have been using a technique to try to improve the pain relief of mastectomy patients. By placing a thin plastic tube beneath the muscle on the chest wall during surgery, we are able to drip local anaesthetic around the nerves that carry pain sensation from the surgical area. This study has been designed to establish whether our method provides a reliable improvement in pain when compared to morphine. Patients agreeing to participate will receive either local anaesthetic or salt water (saline) infused beneath the muscle on the chest wall for 24 hours following surgery. To reduce possible bias, which infusion patients receive will be decided randomly. Patients, hospital staff and researchers will not know which infusion was given. All other treatment will be identical between the two groups of patients. After surgery, all patients will also have a device allowing them to control the amount of morphine they receive by the push of a button. A number of measurements will be taken in hospital and up to six months later including the amount of morphine used and level of pain. Arm movement will be measured and patients will complete a questionnaire concerning arm activities. On study completion, measurements will be compared to determine whether those receiving the local anaesthetic infusion received any different benefit from those that received saline.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  12/SW/0149

• Date of REC Opinion

  1 Jun 2012

• REC opinion

  Favourable Opinion