ERASER Trial

A pragmatic, multicentre, open-label, 1:1 two-arm allocation concealed randomised controlled trial with an internal pilot and 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 Major Trauma Centres (MTCs) across the UK with a track record of participating in critical care research and confirmed access to the MRF patient population. The pilot phase will consist of several MTCs in the UK that have a high number of trauma patients with ≥3 MRF. Upon successful completion of the pilot, further sites will be opened for the main trial.

The trial aims to recruit 824 particpants who meet the eligibility criteria below:

INCLUSION CRITERIA

The site Principal Investigator (PI) will be a medically qualified doctor or an appropriately qualified health care professional and will be responsible for maintaining oversight of the confirmation of the eligibility process. In order to be eligible for the ERASER trial, patients must meet the following inclusion criteria:

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

EXCLUSION CRITERIA

If any of the following exclusion criteria apply, the patient is not eligible to be randomised into the ERASER trial:

1. Severe traumatic brain injury with a predicted ventilatory requirement >7 days
2. Acute quadriparesis
3. Spinal fracture precluding mobilisation
4. Penetrating trauma or open rib fractures
5. Upper airway injury requiring intubation and mechanical ventilation with an expected dependency of more than 5 days (e.g., tracheal disruption)
6. Any chest wall injuries that preclude a catheter insertion
7. Not anticipated to survive ≥48 hours
8. Contamination or infection at the site of potential SAP insertion as deemed by the local PI
9. Any contraindication for SAP block catheter insertion as deemed by the local PI
10. 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

1. Reduces pain

• • Numerical rating scale (0-10), recorded every 4 hours on days 1 to 5, day 14 and before discharge.
  • Patient reported Brief Pain Index (BPI) at 1 and 3 months post randomisation

2. Improves ventilatory function

• • Incentive spirometry peak expiratory flow twice a day

3. Reduces the number of days ventilated and the requirement for invasive/non-invasive methods

• • Number of days ventilated
  • Type of ventilation – invasive/non-invasive

4. Improves mortality

• • Mortality measured at 1 and 3 months post randomisation

5. Is safe and doesn’t have unforeseen complications

• • Measured by Serious Adverse Events (SAEs) review from randomisation until discharge

6. Impacts opiate consumption such as morphine and related compounds

• • Participant opiate consumption measured at discharge and 3 months post randomisation

7. Reduces length of hospital stay

• • Length of stay in hospital and critical care level two/three facility

8. Reduces hospital re-admission within 30 days of discharge

• • Measured by any hospital re-admission within 30 days of discharge

9. Impacts Patient-Reported Outcome Measures:

• • EQ-5D-5L at 1 and 3 months post randomisation
  • Medical Research Council (MRC) dyspnoea scale at 3 months post randomisation
  • BPI at 1 and 3 months post randomisation
  • McGill Pain Questionnaire (SF-MPQ-2) at 1 and 3 months post randomisation

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