{ "abstract": "Objectives This study aims to estimate the rate of recruitment of participants.Design 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 days after pelvic exenteration.Setting Patients will be recruited from three metropolitan quaternary referral centres that offer advanced gastrointestinal surgery in Australia.Participants 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.Interventions 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 days. Participants will be randomised to receive either oral active oxycodone 5–10 mg up to 3 hourly as required (with sublingual placebo) or sublingual active buprenorphine 200–400 mcg 3 hourly as required (with oral placebo).Main outcome measures 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.Ethics and dissemination The trial received ethics approval from Sydney Local Health District, Royal Prince Alfred Hospital Human Research Ethics Committee (No: X25-0128 & 2025/ETH01058). The results of the study will be disseminated by publication and presentation at local annual scientific meetings in Australia.Trial registration number The study protocol is prospectively registered at the Australian New Zealand Clinical Trials Registry (ANZCTR) ( www.anzctr.org.au; ACTRN12625000901404).", "authors": [ { "affiliations": [ "Department of Anaesthesia, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia", "Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia" ], "name": "Charlotte Johnstone" }, { "affiliations": [ "Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Surgical Outcomes Research Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia" ], "name": "Cherry Koh" }, { "affiliations": [ "Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia" ], "name": "Stephanie Mathieson" }, { "affiliations": [ "Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Surgical Outcomes Research Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia" ], "name": "Daniel Steffens" }, { "affiliations": [ "Sydney Nursing School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia" ], "name": "Kate White" }, { "affiliations": [ "The University of Queensland, Brisbane, Queensland, Australia" ], "name": "Paul Gray" }, { "affiliations": [ "The University of Queensland, Brisbane, Queensland, Australia", "The Royal Brisbane & Women's Hospital, Brisbane, Queensland, Australia" ], "name": "Craig Harris" }, { "affiliations": [ "Division of Cancer Surgery, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia", "The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia" ], "name": "Alexander Heriot" }, { "affiliations": [ "Department of Anaesthesia, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia", "Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia" ], "name": "Kaitlin Kramer" }, { "affiliations": [ "NHMRC Clinical Trials Centre, The University of Sydney, Sydney, New South Wales, Australia" ], "name": "Chi Kin Law" }, { "affiliations": [ "Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, Australia" ], "name": "Chung-Wei Christine Lin" }, { "affiliations": [ "The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia" ], "name": "Xiaoqiu Liu" }, { "affiliations": [ "Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Institute for Musculoskeletal Health, Sydney Local Health District, Sydney, New South Wales, Australia" ], "name": "Gustavo Machado" }, { "affiliations": [ "Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia" ], "name": "Andrew McLachlan" }, { "affiliations": [ "Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Department of Pharmacy, Prince of Wales Hospital, Sydney, New South Wales, Australia" ], "name": "Jonathan Penm" }, { "affiliations": [ "The Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, Victoria, Australia", "Department of Critical Care, The University of Melbourne, Melbourne, Victoria, Australia" ], "name": "Bernhard Riedel" }, { "affiliations": [ "Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia", "Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia" ], "name": "Tarik Sammour" }, { "affiliations": [ "Department of Anaesthesia, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia", "Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia" ], "name": "Robert Sanders" }, { "affiliations": [ "Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Surgical Outcomes Research Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia" ], "name": "Michael Solomon" }, { "affiliations": [ "Surgical Outcomes Research Centre, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia" ], "name": "Lilian Whitehead" }, { "affiliations": [ "Department of Colorectal Surgery, St Vincent’s University Hospital, Dublin, Leinster, Ireland" ], "name": "Des Winter" }, { "affiliations": [ "Department of Critical Care, The University of Melbourne, Melbourne, Victoria, Australia", "Department of Anaesthesia, Perioperative Medicine, and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia" ], "name": "Jamie Young" }, { "affiliations": [ "Sydney Pharmacy School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia", "Department of Pharmacy, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia" ], "name": "Asad Patanwala" } ], "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", "uid": "8c607623-a7d7-5d00-9da5-b1db6edb284d" }