PLACEMENT
Research type
Research Study
Full title
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT)
IRAS ID
1006695
Contact name
David Bosanquet
Contact email
Sponsor organisation
Cardiff University
Research summary
Leg amputations are painful and life-changing events. About 10000 people have a leg amputation in the UK every year. Pain may be felt in the stump straight after surgery and in the longer term. Pain may also be felt in the foot which is no longer there. This is called ‘phantom pain’ and may interfere with fitting and using an artificial leg. Long term pain may also delay recovery and limit what people can do for the rest of their lives. Morphine is often used to help with pain. However, morphine has major side effects, including sickness, confusion, and breathing problems. Reducing pain after amputation is an important topic. A 2014 review showed that only 1 out of every 3 patients in the UK had the ‘best’ pain relief after amputation. This research will test a method for managing pain after leg amputation. It involves the surgeon placing a tiny tube, called a ‘perineural catheter,’ next to the main nerve which is cut during surgery. Local anaesthetic is slowly pumped into the tube for up to the first 5 days after surgery. Putting the tube in and taking it out is simple and problems are rare. The tube can replace some (or all) of the morphine often needed. The tube may also reduce phantom pain. The research will be a ‘randomised’ trial. This means patients having amputation surgery will be randomly chosen by a computer to either have the tube or not. Everything else will be the same. All patients will have the best anaesthetic and pain control medication. The amount of pain will then be compared between those who did and those who did not have the tube. This research will take place in 14 NHS hospitals. 650 patients having an amputation because of blocked arteries and/or diabetes will take part. The amount of pain, morphine used, painkiller side effects, and surgery complications will be recorded for up to 5 days after the amputation surgery. We will ask patients about their pain and if they are walking on an artificial leg 3 and 6 months after their amputation.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0020
Date of REC Opinion
1 Aug 2023
REC opinion
Further Information Favourable Opinion