Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment
Introduction Patients with rib fractures commonly experience significant acute pain and are at risk of hypoxia, retained secretions, respiratory failure and death. Effective analgesia improves these outcomes. There is widespread variation in analgesic treatments given to patients including oral, int...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/9/e062935.full |
| _version_ | 1797997160956952576 |
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| author | Matthew L Costa Peter Bates Reuben Ogollah Simon Craxford Benjamin J Ollivere Nigel M Bedforth David W Hewson Jessica Nightingale |
| author_facet | Matthew L Costa Peter Bates Reuben Ogollah Simon Craxford Benjamin J Ollivere Nigel M Bedforth David W Hewson Jessica Nightingale |
| author_sort | Matthew L Costa |
| collection | DOAJ |
| description | Introduction Patients with rib fractures commonly experience significant acute pain and are at risk of hypoxia, retained secretions, respiratory failure and death. Effective analgesia improves these outcomes. There is widespread variation in analgesic treatments given to patients including oral, intravenous and epidural routes of administration. Erector spinae plane (ESP) blockade, a novel regional analgesic technique, may be effective, but high-quality evidence is lacking.Methods and analysis To determine if a definitive trial of ESP blockade in rib fractures is possible, we are conducting a multicentre, randomised controlled pilot study with feasibility and qualitative assessment. Fifty adult patients with rib fractures will be randomised in a 1:1 ratio to ESP blockade with multimodal analgesia or placebo ESP blockade with multimodal analgesia. Participants and outcome assessors will be blinded. The primary feasibility outcomes are recruitment rate, retention rate and trial acceptability assessed by interview.Ethics and dissemination The study was approved by the Oxford B Research Ethics Committee on 22 February 2022 (REC reference: 22/SC/0005). All participants will provide written consent. Trial results will be reported via peer review and to grant funders.Trial registration number ISRCTN49307616. |
| first_indexed | 2024-04-11T10:28:31Z |
| format | Article |
| id | doaj.art-dae7363b3f864a37943eae9f41281885 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T10:28:31Z |
| publishDate | 2022-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-dae7363b3f864a37943eae9f412818852022-12-22T04:29:30ZengBMJ Publishing GroupBMJ Open2044-60552022-09-0112910.1136/bmjopen-2022-062935Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessmentMatthew L Costa0Peter Bates1Reuben Ogollah2Simon Craxford3Benjamin J Ollivere4Nigel M Bedforth5David W Hewson6Jessica Nightingale7Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford University, Oxford, UKBarts Health NHS Trust, London, UKNottingham Clinical Trials Unit, University of Nottingham, Nottingham, UKAcademic Unit of Injury, Recovery and Inflammation Sciences, School of Medicine, University of Nottingham, Nottingham, UKAcademic Unit of Injury, Recovery and Inflammation Sciences, School of Medicine, University of Nottingham, Nottingham, UKDepartment of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UKDepartment of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UKTrauma and Orthopaedics, Nottingham University Hospitals NHS Trust, Nottingham, UKIntroduction Patients with rib fractures commonly experience significant acute pain and are at risk of hypoxia, retained secretions, respiratory failure and death. Effective analgesia improves these outcomes. There is widespread variation in analgesic treatments given to patients including oral, intravenous and epidural routes of administration. Erector spinae plane (ESP) blockade, a novel regional analgesic technique, may be effective, but high-quality evidence is lacking.Methods and analysis To determine if a definitive trial of ESP blockade in rib fractures is possible, we are conducting a multicentre, randomised controlled pilot study with feasibility and qualitative assessment. Fifty adult patients with rib fractures will be randomised in a 1:1 ratio to ESP blockade with multimodal analgesia or placebo ESP blockade with multimodal analgesia. Participants and outcome assessors will be blinded. The primary feasibility outcomes are recruitment rate, retention rate and trial acceptability assessed by interview.Ethics and dissemination The study was approved by the Oxford B Research Ethics Committee on 22 February 2022 (REC reference: 22/SC/0005). All participants will provide written consent. Trial results will be reported via peer review and to grant funders.Trial registration number ISRCTN49307616.https://bmjopen.bmj.com/content/12/9/e062935.full |
| spellingShingle | Matthew L Costa Peter Bates Reuben Ogollah Simon Craxford Benjamin J Ollivere Nigel M Bedforth David W Hewson Jessica Nightingale Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment BMJ Open |
| title | Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| title_full | Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| title_fullStr | Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| title_full_unstemmed | Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| title_short | Erector Spinae Plane Blocks for the Early Analgesia of Rib Fractures in Trauma (ESPEAR): protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| title_sort | erector spinae plane blocks for the early analgesia of rib fractures in trauma espear protocol for a multicentre pilot randomised controlled trial with feasibility and embedded qualitative assessment |
| url | https://bmjopen.bmj.com/content/12/9/e062935.full |
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