Title: Erector Spinae Plane blocks for the Early Analgesia of Rib fractures in trauma: a feasibility randomised controlled trial with embedded qualitative assessment (ESPEAR trial).
Funder: Department of Health and Social Care

Abstract: Research question Is it feasible to undertake a definitive randomised controlled trial (RCT) to establish if erector spinae plane (ESP) blocks are a clinically effective early treatment for patients hospitalised with rib fractures? Background Patients with rib fractures are at high risk of atelectasis, hypoventilation and hypoxaemia leading to respiratory failure, mechanical ventilation and death. Effective early analgesia improves respiratory mechanics and patient outcomes. Data to support one analgesic strategy over another is currently lacking and there is wide variation in NHS practice. Erector spinae plane blocks are a simple regional anaesthetic technique for chest wall pain already used for patients in many UK centres. The effectiveness of ESP blocks for rib fractures is unknown. Aims and Objectives The aim of this feasibility randomised controlled study, with an embedded qualitative study, is to assess the feasibility and inform the design and conduct of a pragmatically conducted, interventional, multi-centre RCT in adult patients admitted to UK major trauma centres with rib fractures examining ESP block as an analgesic adjunct to existing multimodal analgesia in the early management of rib fracture pain. The objectives are: 1. Patient feasibility a) Study screening, recruitment and retention rate. b) Assess the acceptability of the intervention to participants. c) Describe complications of the intervention. 2. Outcomes feasibility a) Establish the feasibility of collection of our candidate clinical and safety outcome measures. 3. Site and clinician feasibility a) Assess proposed data-collection systems for data completeness and integrity. b) Systematically identify potential causes of protocol violation and trial withdrawal. In addition this project will use qualitative approaches to: 4. Highlight barriers and facilitators to recruitment and retention of trial participants. 5. Obtain feedback on the effectiveness of blinding strategies. Methods Feasibility RCT: Population: Adult patients admitted to three NHS Major Trauma Centres with rib fractures. Intervention: Ultrasound-guided ESP block and infusion sited on admission to hospital plus multimodal analgesia. Comparator: Sham ultrasound-guided ESP block and infusion sited on admission to hospital plus multimodal analgesia. Outcomes: Outcome measures are divided into feasibility assessments, clinical and safety outcomes measures. Embedded qualitative study: We will use embedded semi-structured interviews of potential and actual participants, clinicians and investigators to assess the acceptability of proposed trial interventions and assessments. We will also assess the effectiveness of our blinding strategy. Timelines for feasibility RCT delivery Month 6: Completion of methodology, protocols, submission for regulatory/site approvals. Month 12: Completion of site initiation visits, training and recruitment commenced at all three sites. Month 24: Completion of recruitment. Month 30: Completion of data cleaning and analysis, dissemination of trial findings, progression criteria assessment. Anticipated impact and dissemination Red-amber-green progression criteria of recruitment rate relative to target, retention rate and the support of the embedded qualitative study report are proposed. If progression criteria are met we will apply for definitive RCT support, via NIHR HTA, within 12 months of study completion. Feasibility methodology and findings will be disseminated via Open Access publication, scientific conference and our PPI network and social media.

Lay abstract: Broken ribs are a common and very painful injury that can cause people to struggle to breathe after falls and accidents. Patients often tell us the pain is &quot;unbearable&quot; every time they breathe in or move around. Without good pain relief to help them breathe, people may suffer low blood oxygen levels, chest infections and can die. We don't have a perfect way to give people pain relief for their broken ribs, but doctors try combinations of tablets, strong painkillers in the drip, epidural injections and even surgery to help. Physiotherapy and careful nursing care is also really important to help people recover. But there is no perfect pain relief 'recipe' that works for every person every time. We are a group of experts in anaesthesia (specialists in pain relief), trauma surgery (caring for people with broken ribs in specialist hospitals), trial methodology (how to run successful research) and patient engagement (getting people themselves involved in research). We have listened to feedback from our patient and public involvement group (formed of people who have had broken ribs), who think it is important to improve the way we care for people with broken ribs and give people better pain relief as soon as they come to hospital with their injuries. We want to test if a new method of pain relief - called an erector spinae plane (ESP) block - can help people with broken ribs get better pain relief and reduce their risk of getting chest problems. ESP blocks are injections, like an epidural, that are simple to do and suitable for almost everyone. We know they help people after operations but we don't know if they can help with broken ribs. To test ESP blocks properly we need to do a large clinical trial at lots of hospitals that care for people with broken ribs. Before we launch into such a big project it is important to 'test the water' and make sure we design that trial properly and understand what problems we might encounter. We are asking for this award to do a smaller, but vital, study (called a feasibility study) to do this. The feasibility study will run at three UK hospitals caring for people with broken ribs. We will see if adding an ESP block to the existing 'recipes' for pain relief for broken ribs makes a difference to people's pain relief and risk of becoming more unwell. We will collect data (for example pain scores) and do interviews (with patients and local researchers) which will help us design a really well thought-out large trial. If this feasibility study works, we will ask for support for a larger trial within 12 months of finishing this project.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INJURIES AND ACCIDENTS