PLACEMENT A phase III clinical trial examining the use of perineural catheters after major lower limb amputation in adults with critical limb ischaemia
Recipient organisationNIHR Nottingham Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodMar 2025 — Mar 2026
In plain English
AI plain-English summary
Every year, around 10,000 people in the UK have a leg amputated, and most endure severe stump and phantom-limb pain that morphine—with its side effects of sickness, confusion, and breathing problems—manages poorly. This trial tests a simple alternative: a surgeon places a tiny tube (a perineural catheter) next to the cut nerve during surgery and pumps local anaesthetic through it for up to five days, replacing some or all of the morphine. The problem is that a 2014 review found only one in three UK patients received optimal pain relief after amputation. If the tube works, it could cut morphine use, reduce phantom pain, and speed recovery—helping people walk on an artificial leg sooner and avoid long-term disability. The trial will randomise 650 patients across 14 NHS hospitals, comparing pain levels, morphine consumption, side effects, and walking ability at three and six months. Success would give surgeons a straightforward, low-risk tool to improve outcomes after a life-changing surgery.
View original technical description
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.
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