PLACEMENT
Research type
Research Study
Full title
Perineural Local Anaesthetic Catheter aftEr Major lowEr limb amputatioN Trial (PLACEMENT)
IRAS ID
180845
Contact name
David Bosanquet
Contact email
Sponsor organisation
Aneurin Bevan University Health Board
Eudract number
2016-003544-37
ISRCTN Number
ISRCTN85710690
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
A perineural catheter (PNC) is a tiny tube placed next to the main nerve cut during a leg amputation, through which local anaesthetic is infused after surgery. It has few known complications and can partly replace strong painkillers such as morphine. This research is designed to assess the feasibility of studying the effects of a PNC on postoperative pain and other outcomes. We also plan parallel qualitative research to identify important outcomes for patients and doctors (Core Outcome Sets: COS), which do not currently exist for amputation research.
Postoperative pain after amputation was identified as a key problem when we ran a patient and public involvement event to gather information during development of the trial. This is a national problem, as a recent UK government review showed only 37.5% of patients had good pain relief after amputation. Poorly controlled pain can delay recovery and discharge from hospital. It can also lead to long term ‘phantom’ pain (pain felt in the amputated limb despite it not being present) and reduced chanceS of walking. This is expensive and can seriously impact quality of life. Morphine is commonly used, but comes with unpleasant and potentially dangerous side effects, and is not always completely effective.
Patients undergoing amputation for blocked arteries will be randomised to receive either a PNC and usual pain relief, or usual pain relief alone. The study will recruit 50 patients from 2 centres. Pain scores, morphine use, side effects and complications will be collected 3 times daily for 5 days. Patients will also be contacted at and 6 months after amputation to grade pain in the stump or 'phantom pain' in the foot which has been amputated, and evaluate costs and quality of life. Interviews and focus groups will be held to investigate qualitative outcomes and develop Core Outcome Sets.
REC name
Wales REC 3
REC reference
16/WA/0353
Date of REC Opinion
21 Nov 2016
REC opinion
Further Information Favourable Opinion