{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T15:48:01Z","timestamp":1782143281743,"version":"3.54.5"},"reference-count":36,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"unspecified","delay-in-days":21,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["MRF2036291"],"award-info":[{"award-number":["MRF2036291"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,5,27]]},"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>This study aims to estimate the rate of recruitment of participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>This is a pilot, multicentre, double-blind, placebo-controlled, randomised controlled trial of oral oxycodone and sublingual placebo vs sublingual buprenorphine and oral placebo for postoperative pain management for 7\u2009days after pelvic exenteration.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Patients will be recruited from three metropolitan quaternary referral centres that offer advanced gastrointestinal surgery in Australia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>The inclusion criteria will be patients over the age of 18 years undergoing pelvic exenteration surgery and exclusion criteria are previous adverse events related to the study drugs, currently requiring monoamine oxidase inhibitor medications and if epidural analgesia is planned in the perioperative period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Enrolled patients will undergo pelvic exenteration surgery and be initiated postoperatively on patient-controlled analgesia. In the postoperative period, when clinically appropriate to take oral medications, patients will be commenced on trial analgesia for 7\u2009days. Participants will be randomised to receive either oral active oxycodone 5\u201310\u2009mg up to 3 hourly as required (with sublingual placebo) or sublingual active buprenorphine 200\u2013400\u2009mcg 3 hourly as required (with oral placebo).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>The primary outcome measure is the rate of recruitment over a 6-month period. Secondary outcomes include an assessment of missing data, protocol adherence and acceptability of the trial to participants.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The trial received ethics approval from Sydney Local Health District, Royal Prince Alfred Hospital Human Research Ethics Committee (No: X25-0128 &amp; 2025\/ETH01058). The results of the study will be disseminated by publication and presentation at local annual scientific meetings in Australia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      The study protocol is prospectively registered at the Australian New Zealand Clinical Trials Registry (ANZCTR) (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"www.anzctr.org.au\">www.anzctr.org.au<\/jats:ext-link>\n                      ; ACTRN12625000901404).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-117594","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T14:56:21Z","timestamp":1782140181000},"page":"e117594","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Oral oxycodone versus sublingual buprenorphine for postoperative pain control after pelvic exenteration (PROSPER): a pilot, registry-embedded, multi-centre, double-blind, placebo-controlled, randomised controlled trial"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4312-5084","authenticated-orcid":false,"given":"Charlotte","family":"Johnstone","sequence":"first","affiliation":[{"name":"Department of Anaesthesia, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia"},{"name":"Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, 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