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

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. 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. 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. 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). 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. 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. 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.