David Bosanquet (South East Wales Vascular Network, Cardiff, UK) is chief investigator of a new randomised trial—PLACEMENT—which addresses the topic of pain control around the time of a major amputation. Here, he speaks to Vascular News about the importance of such a trial, the challenges associated with conducting a randomised study, and the central involvement of the patient voice in this new research.
What is the PLACEMENT trial about?
DB: The PLACEMENT trial will assess whether placing a nerve catheter—through which it is possible to administer five days’ worth of local anaesthetic— impacts pain and other outcomes compared to no nerve catheter in patients who have undergone a major amputation. In terms of available data on the topic, we previously conducted a meta-analysis, and there are observational and some relatively poor-quality randomised data out there. However, there are no good, solid, robust data to conclusively evaluate if a nerve catheter improves outcomes, which is why we have developed this study: to answer that key question.
Why is this trial important?
DB: PLACEMENT is a good opportunity to educate readers about the importance of good pain control around the time of amputation. Good pain control was recently picked up as a key priority in the James Lind Alliance priority setting. We asked patients, carers and healthcare professionals, ‘What are the important research priorities in amputation and how do you order them?’ Priority number four was highlighted as ‘What are the best ways to prevent or treat pain, including phantom pain, after amputation?’ So, pain control has been identified as an important priority when it comes to research around amputation. In addition, although I do not have conclusive evidence for this, anecdotally amputation surgery has received significantly less interest from the vascular research community compared to aortic interventions, stents for peripheral vascular disease or carotid surgery. Moreover, looking at something like money spent in big randomised controlled trials (RCTs) or recruitment to RCTs, you find that a number of patients go into RCTs for carotid surgery and lower limb intervention, but very few are recruited for amputation surgery trials.
Could you outline how the study links with the Limbless Association Volunteer Visitor Scheme?
DB: During study setup for PLACEMENT, we put together focus groups of patients and presented the research to them. We asked about things like primary outcomes and how we should collect data, and the groups provided us with some really important feedback. A few individuals spoke about their time during amputation surgery, and they said that while the clinical team can inform them about risks of surgery, when it comes to quality of life, that information is often not given to patients, as we do not have lived experience as clinicians. That prompted us to set up a smaller working group to find out if this was something that we could address. We then found out that the Limbless Association Volunteer Visitor Scheme already fills this gap, and so we linked with them. The Limbless Association now formally supports PLACEMENT. As a direct result of the patient input from these focus groups, every recruiting participant to PLACEMENT will be given information about the Limbless Association Volunteer Visitor Scheme, which is free. Within the scheme, every patient gets buddied up with somebody who has already had an amputation, and they get time to talk through the process with them either before or after surgery, about how it will affect their life. These are people who are experts in their own right, and they can provide invaluable information about what life is really like after an amputation, how to engage services which support people after amputation, and direct patients towards other avenues of the scheme’s support network. I think that is really exciting. We speak to patients before every study, and they have an integral part in shaping and designing them, but for them to play such a major role is really quite interesting. We are hoping to do a bit of extra research around this point, asking patients to engage with the programme and tell us whether or not they find it helpful and why.
Across the UK there may be centres where this is done already and done very well, but certainly, there will be lots of centres where this is done either on an ad hoc basis or hardly at all.
In June, the Limbless Association celebrated three years of their National Lottery funding, and PLACEMENT was presented at that meeting.
This is a randomised control trial—could you outline some of the challenges associated with conducting this type of research?
DB: I think the biggest challenge is going to be the equipoise of treating clinicians. There is a widely held view that catheters are of benefit in patients who have undergone an amputation, and so it will be challenging trying to get that balance between doing what you think is best for the patient based on the limited data that are available compared to the longer-term view and broader question about providing robust evidence to base practice on. Equipoise is a challenging issue, and, unsurprisingly, PLACEMENT is not exempt from that challenge.
It is important to remember that there are lots of examples of RCTs done in vascular surgery and general surgery where it was thought ‘the answer’ to the study was a foregone conclusion, and yet when the study was conducted it was found that the opposite was true. Therefore, I do appreciate that there is that question mark over whether we should we just put catheters in every single patient, but we do not have good clinical evidence about their effectiveness, we do not really understand what has the impact on long-term follow up, and we do not know about cost-effectiveness.
In addition, there is significant variability in practice on an international level. We have had fellows come from countries such as Egypt and Bahrain and they have never seen a nerve catheter, for example. Even in the UK, we conducted a survey and found that approximately 60% of centres use a catheter most of the time. While that is not exactly a 50:50 split, there is clearly still variation within UK practice as to what people do.
When do you hope to start the trial?
DB: We recently received ethical and UK Medicines and Healthcare products Regulatory Agency (MHRA) approval and hope to commence the trial in September.