ERASER Trial

A pragmatic, multicentre, open-label, 1:1 two-arm allocation concealed randomised controlled trial with an internal pilot complete economic evaluation.

The trial aims to evaluate the clinical and cost-effectiveness of SAP with usual care compared with usual care only in adult patients with MRF admitted to the hospital. This will be achieved by determining whether treating MRF patients with SAP decreases the rates of pneumonia 5 days after randomisation, as defined by a blinded end point review committee using the Clinical Pulmonary Infection Score (CPIS) and all available trial related clinical information.

The ERASER trial aims to answer a vital question for both patients and clinicians with the prospect of improving patient comfort, care and outcome, and costs in the NHS. The results of this study will have a significant impact in 2 different ways:

Patient benefit: if the trial finds that either treatment protocols reduce acute pain and pneumonia, maintains patient safety, and is cost-effective, it will significantly impact the way patients with MRF in the NHS are currently managed.

Change in practice: if SAP is effective, it will lead to a consensus on the preferred usual care for patients with MRF and prompt rapid change to NICE guidance, with the consequential amendment to care pathways and resource use across the NHS. However, importantly if there were no benefit, the trial would provide evidence to stop the use of the ineffective treatment within the NHS.

The trial will take place both on wards and Intensive Care Units (ICUs) within NHS Trauma Centres (TCs) across the UK with a track record of participating in critical care research and confirmed access to the MRF patient population.  The pilot phase consisted of UK trauma centres that have a high number of trauma patients with ≥3 MRF.  The pilot was successfully completed on 31st March 2024.

The trial aims to recruit 824 participants with 90% power, which on current recruitment rate will not be reached until January 2028.  Therefore, the BCTU statistics team recalculated the target population based on 80% power and this new target will be 618 participants, which will be met on January 2027. 

All the eligibility criteria must be met to join the trial and is listed below:

Inclusion Criteria

• Aged ≥16 years
• with unilateral or bilateral ≥3 rib fractures following blunt chest trauma
• Traumatic injury that occurred ≤72 hours before hospital admission.

Exclusion Criteria

• Severe traumatic brain injury with a predicted ventilatory requirement >7 days
• Acute quadriparesis
• Spinal fracture precluding mobilisation
• Penetrating trauma or open rib fractures
• Upper airway injury requiring intubation and mechanical ventilation with an expected dependency of more than 5 days (e.g., tracheal disruption)
• Any chest wall injuries that preclude a catheter insertion
• Not anticipated to survive ≥48 hours
• Contamination or infection at the site of potential SAP insertion
• Any contraindication for the SAP block catheter insertion
• Patients of childbearing age who have tested positive for pregnancy

The Eraser trial is a 1:1 two-arm allocation concealed randomised control trial

Intervention arm: SAP + Usual care

SAP catheter inserted, under ultrasound guidance, in the lateral chest wall between latissimus dorsi and serratus anterior muscles in the midaxillary line.  A local anaesthetic will be infused using a continuous infusion pump, according to local standard practice.

Control arm: Usual care only

Usual NHS trauma care, which may consist of twice a day physiotherapy, multimodal analgesia, incentive spirometry when possible and rib fixation.

Primary Outcome

New diagnosis of pneumonia, as agreed by a blinded end point assessment committee, 5 days after randomisation.

Secondary Outcomes

• Pain assessed using a numerical rating scale (0-10), recorded approximatelt 4-6 hours, day 1 to 5, day 14 and before discharge, and by the patient-reported BPI at one and three-months post-randomisation.
• Number of days ventilated and the requirement for invasive/non-invasive methods
• 30-day and 90-day mortality
• Complications and safety data associated with SAP
• Opiate consumption such as morphine and related compounds
• Length of stay in hospital and critical care level two/three facility
• Hospital re-admission within 30 days of discharge
• Patient-Reported Outcome Measures (PROMs) at 30 and 90 days:
  • • • • EQ-5D-5L
        • Medical Research Council (MRC) dyspnoea scale at 90 days only
        • Brief Pain Index (BPI)
        • McGill Pain Questionnaire (SF-MPQ-2)

Funder: National Institute of Health Research (Reference: NIHR130632)

Sponsor: University of Birmingham (Reference: RG_20-064)

REC reference: 22/LO/0607

IRAS ID: 30762

ISRCTN number: ISRCTN16156075