Title: ERASER TRIAL: Early Rib Analgesia with Serratus. A Pragmatic Randomised Control Trial evaluating the clinical and cost-effectiveness of Serratus Anterior Plane Block with catheter insertion compared to Usual Care in patients with multiple rib fractures
Funder: Department of Health and Social Care

Abstract: Lay Summary _x000D_ Aim: To find out if a newly developed regional nerve block (called a Serratus Anterior Plane block or SAP for short) reduces the rate of chest infection in patients with broken ribs, compared with those receiving usual care in the NHS._x000D_ Background: Broken ribs are common, extremely painful and can lead to severe complications. The pain stops patients from coughing and moving effectively, leaving them unable to clear fluids and increasing the risk of developing severe infections like pneumonia and sepsis. Broken ribs are costly for the NHS and remain a significant health and economic burden in the UK. Broken ribs affect up to 10% of patients who are admitted to hospital following road traffic collisions and falls. 40% of these patients are of working age, and 60% of these patients do not return to full-time employment five years after their injury. _x000D_ Morphine is commonly used to treat pain after broken ribs, although it can cause nausea, sickness, confusion and suppression of breathing. Thoracic epidurals were once considered the gold standard of pain management. They work by continuously infusing anaesthetic around the spinal cord, blocking the conduction of pain. However, epidural is only suitable for less than 20% of patients because of their complications. The Serratus Anterior Plane block (SAP) is a new technique, where the anaesthetic is injected between chest wall muscles. This blocks the pain caused by broken ribs. We have evaluated the effectiveness of SAP in 354 patients where it was found to be a safe, effective and accessible pain management option. This technique can be quickly taught to clinical staff. _x000D_ Design and Methods: This multicenter randomised controlled trial (RCT) will compare SAP with the usual care for the management of pain caused by broken ribs. Eight hundred and twenty-four participants, with multiple rib fractures admitted to trauma centres will be invited to take part. Half of them will receive SAP and the other half usual care. Which treatment they receive will be decided by chance using a computer formula provided by the Birmingham Clinical Trials Unit. The main aim of the study is to investigate if SAP block reduces the rate of a chest infection at five days after randomisation. We will also record other complications, the quality of the pain relief, effectiveness of coughing, patient feedback on their breathing and ability to take part in daily activities and deaths._x000D_ Patient and Public Involvement(PPI): We are working closely with the British Association of Trauma. This application is the production of a series of meetings with survivors, family members and carers of patients with trauma experience, members of the NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC) and NIHR Trauma Management MedTech Co-operative PPI group. These groups expressed their strong support for the proposal. Our PPI co-applicants helped us to develop this plain English summary, inclusion criteria and measurements of outcomes. They will be an integral part of our trial Management Team. They will also advise on the Patient Information sheet, consent process, trial delivery and dissemination of the trial results.

Lay abstract: Research question: Does the newly developed regional nerve block (serratus anterior plane block, SAP) reduce the rate of a chest infection at five days after randomisation in patients with multiple rib fractures (MRF), compared with the usual care in the NHS trauma settings._x000D_ Background: 16% of patients suffering from major trauma have rib fractures, and this often leads to a significant risk of morbidity and mortality. Conservatively managed rib fractures cost approximately £7000 per patient, in the acute setting. Opiate based pain relief is the current usual care despite its adverse effects like delirium, cough and respiratory suppression. Patients with MRFs require a simple, safe, effective and universally available analgesic option. Serratus Anterior Plane Block (SAP), where the catheter is inserted in the lateral chest wall provide a simple, easy, safe and effective analgesic delivery technique in the majority of patients up to 10 days._x000D_ Aims and objectives: To conduct a pragmatic multicentre randomised controlled trial (RCT) to compare clinical and cost-effectiveness between SAP and usual care after MRF. The primary hypothesis is that SAP is more effective than usual care for the treatment of pain and preventing pneumonia after multiple rib fractures (MRF), improving clinical outcomes and cost-effectiveness._x000D_ Methods and outcomes: Multicentre, allocation concealed, open-label, randomised controlled clinical and cost-effectiveness trial with an internal pilot. This trial would be conducted in ten major trauma centres in NHS hospitals with patient case-mix typical of UK trauma, who manage adults with severe injury and multiple rib fractures, will participate in the trial. The primary outcome is the rates of pneumonia, defined by diagnosis of pneumonia (clinical pulmonary infection score in ventilated patients) and NICE guidance in non-ventilated patients at five days after randomisation. Secondary outcomes include pain scores, ventilatory function, the necessity for invasive/non-invasive ventilation, mortality at 3-months, Opiate consumption at discharge and three months, length of stay in the hospital, readmission to the hospital within 30 days, Health Economics Analysis and Patient-Reported Outcome Measures (PROMs)._x000D_ Project timeline: Start-up – 6 months; internal pilot – 12 months; full trial recruitment – 33 months; follow-up- 3 months and close down & analysis - 6 months, total 60 months._x000D_ Anticipated impact: If the trial finds that treatment with SAP reduce pneumonia and acute pain and is cost-effective, it would have a significant effect on the way we currently manage patients with MRF in the NHS. This will change practice, lead to consensus on the preferred standard-of-care for patients with MRF, prompt changes to NICE guidance, an amendment to care pathways and resource use across the NHS. Importantly if there were no benefit, the trial would provide evidence to stop the use of the ineffective treatment within the NHS. _x000D_ Dissemination: The study findings will be presented at national and international meetings with abstracts on-line and comprehensive social media coverage so that results and their implications quickly reach all of the relevant UK clinical communities. We will publish the clinical findings of the trial as well as a paper describing the cost-effectiveness in the NHS setting in high quality peer-reviewed open access (via PubMed) journals. A final report will also be published in the NIHR HTA journal.

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