{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T09:01:26Z","timestamp":1791536486739,"version":"4.3.4"},"reference-count":44,"publisher":"BMJ","issue":"11","content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,10,16]]},"published-print":{"date-parts":[[2019,11]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Randomised controlled feasibility trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Two vascular Centres in South Wales, UK.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>The treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>The primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6\u2009month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Seventy-six of 103 screened patients were deemed eligible over a 10\u2009month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6\u2009month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Recruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ISRCTN: 85\u2009710\u2009690. EudraCT: 2016-003544-37.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-029233","type":"journal-article","created":{"date-parts":[[2019,11,12]],"date-time":"2019-11-12T04:55:34Z","timestamp":1573534534000},"page":"e029233","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): results from a randomised controlled feasibility trial"],"prefix":"10.1136","volume":"9","author":[{"given":"David C","family":"Bosanquet","sequence":"first","affiliation":[{"name":"Department of Vascular Surgery, Aneurin Bevan University Health Board, Newport, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Graeme K","family":"Ambler","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Aneurin Bevan University Health Board, Newport, UK"},{"name":"Division of Population Medicine, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cherry-Ann","family":"Waldron","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emma","family":"Thomas-Jones","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Brookes-Howell","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Kelson","sequence":"additional","affiliation":[{"name":"Department of Mathematics, College of Engineering, Mathematics and Physical Sciences, University of Exeter, Exeter, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Pickles","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Debbie","family":"Harris","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Milosevic","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deborah","family":"Fitzsimmons","sequence":"additional","affiliation":[{"name":"Swansea Centre for Health Economics, College of Human Health Sciences, Swansea University, Swansea, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neeraj","family":"Saxena","sequence":"additional","affiliation":[{"name":"Department of Anaesthetics, Royal Glamorgan Hospital, Cwm Taf University Health Board, Abercynon, UK"},{"name":"CUBRIC, School of Psychology, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher P","family":"Twine","sequence":"additional","affiliation":[{"name":"Department of Vascular Surgery, Aneurin Bevan University Health Board, Newport, UK"},{"name":"Division of Population Medicine, Cardiff University, Cardiff, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2019,11,11]]},"reference":[{"key":"2025121223184811000_9.11.e029233.1","first-page":"33","article-title":"Optimal management of peripheral arterial disease for the non-specialist","volume":"80","author":"O'Donnell","year":"2011","journal-title":"Ulster Med J"},{"key":"2025121223184811000_9.11.e029233.2","unstructured":"VSGBI . 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