Perineural local anaesthetic catheter after major lower limb amputation trial.
The management of pain following an amputation is essential for short-term recovery and rehabilitation. Amputees suffer from different types of pain: immediate postoperative pain, chronic stump pain (pain localised to the residual portion of the limb) and phantom limb pain (experienced where the limb used to exist). How best to manage this pain is unclear.
The Perineural Local Anaesthetic Catheter after major lower limb amputation trial (PLACEMENT) is a phase II randomised controlled feasibility study looking at a new way of managing pain following amputation. This new method involves placing a perineural catheter (PNC – a tiny tube placed next to the main nerve cut during a leg amputation), through which local anaesthetic is infused after surgery. We want to compare this method with usual care. This research is designed to assess the feasibility of studying the effects of a PNC on postoperative pain and other outcomes.
Participants 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 participants from 2 centres.
Participants in the study will also be interviewed so we can find out which outcomes are most important to patients as well as how the intervention was for them.
This study will provide crucial evidence to allow for the appropriate design of a trial to explore whether this new method is better than usual care.
The PLACEMENT trial has demonstrated that recruitment into a randomised controlled trial evaluating the effectiveness of a PNC on postoperative pain in patients undergoing major lower limb amputation is feasible.
A total of 50 patients were randomised between February 2017 and November 2017. Recruitment rates were good and 60% of all eligible patients were recruited.
Both patients and healthcare professionals found the trial processes acceptable.
A grant application will be made for a larger scale randomised controlled trial in order to evaluate whether insertion of a PNC is effective in reducing postoperative pain in patients undergoing major lower limb amputation.
|Start date||1 Oct 2016|
|End date||1 Sep 2018|