Every year, roughly 650 patients undergoing major leg amputation in UK hospitals will be randomly assigned to receive either a local anaesthetic catheter placed beside the nerve for five days after surgery, or standard pain management without one. Pain after a major lower-limb amputation is a serious and persistent problem. It includes both acute surgical pain and chronic phantom limb pain, which can last for years. A perineural catheter is quick to insert during surgery and has few side effects, but no good-quality data exist to prove whether it actually improves outcomes. Current use across the NHS is inconsistent, with no evidence-based guidance to standardise practice. If the trial shows that the catheter reduces pain and improves recovery, the finding could change routine NHS care for thousands of patients each year. Better pain control in the first five days may reduce long-term phantom pain, lower opioid use, and speed up prosthetic fitting—directly affecting a patient’s ability to walk again and return to daily life. The trial also includes a cost-effectiveness analysis, so the NHS would know whether the intervention is worth funding at scale. Results will be shared with national guideline bodies and parliamentary groups to drive adoption.
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RESEARCH QUESTION: Does the use of a perineural catheter (PNC) with local anaesthetic infusion, placed at the time of major lower limb amputation (MLLA), impact on pain and other patient-centred outcomes after surgery? BACKGROUND: Pain after MLLA is a significant problem, and comprises both acute and chronic pain, including phantom limb pain. A PNC, a type of peripheral nerve catheter, is quick and simple to insert at the time of surgery. Its insertion and use for local anaesthetic infusion comes with few side effects, but benefits remain unclear. Our recent systematic review showed no good quality data are available on which to base practice. Our recent survey demonstrated PNC use is variable across the UK. Previously, we completed a randomised feasibility study of PNC use in MLLA which recruited ahead of schedule and allowed us to refine outcome measures. AIMS: The primary aim is to evaluate the clinical and cost-effectiveness of a PNC with continuous local anaesthetic infusion, inserted at the time of MLLA, on postoperative outcomes, compared with no PNC. METHODS: This is a randomised non-blinded pragmatic effectiveness study. 650 adult patients undergoing MLLA for peripheral arterial disease and/or diabetes will be randomised in a 1:1 ratio to receive either the PNC with local anaesthetic infusion for the first 5 postoperative days, or not. The primary outcome is ‘freedom from pain’, defined as the proportion of time points with self-reported pain <4 on a 0-10 Numerical Rating Scale, assessed twice daily for the first 5 postoperative days. Overall satisfaction with analgesia, total opioid use and early complications will be measured. Long-term outcomes, including, pain, quality of life, cost effectiveness and rate and timing of prosthetic fitting will also be evaluated. A qualitative evaluation of PNC implementation will be conducted, comprising semi-structured interviews with trial participants and healthcare professionals. TIMELINES: Our recruitment estimate is based on our feasibility recruitment rate, which averaged 2.50 participants/site/month, including set-up time. Month 1-6: Study set-up, contracts, regulatory approvals Month 7-14: Internal pilot, site set-up (n=7, staffed by co-applicants) and recruitment (n=98, rate:2.03 participants/site/month). Month 15: Review of internal pilot Month 15-30: Complete site set-up (n=14) and recruitment (2.49 participants/site/month). Month 36: Last patient last follow-up Month 37-42: Data cleaning, statistical and health economic analysis, prepare report, draft paper, stakeholder event. ANTICIPATED IMPACT AND DISSEMINATION: We anticipate PLACEMENT will provide definitive evidence for the effectiveness of PNC usage at the time of MLLA. We will run a multi-stakeholder ‘pathway-to-impact’ event, inviting trial team members, patient representatives, charities and healthcare policy maker, with support from the Vascular Society Amputation ‘Special Interest Group’ to ensure the findings are widely disseminated and positive findings are translated into clinical practice. Patient-facing documents will be circulated via charities and other national organisations. We will share our results with the Vascular and Venous All Party Parliamentary Group and the national media. The team (including our PPI representatives) are active on social media, via which the results will be publicised. We envisage results will be referenced in national and international guidelines.
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