Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency Pre-Hospital hip fracture care Delivery (RAPID 2)
Paramedics will be trained to inject a local anaesthetic into the hip joint of patients with suspected fractures, before they reach hospital, in a trial involving 1,400 patients across five sites in England and Wales. Each year, roughly 75,000 people in the UK fracture a hip. The pain is severe, and standard treatment—intravenous morphine—can cause nausea, delirium, and breathing problems that delay surgery and worsen outcomes. A smaller feasibility study has already shown that paramedic-administered Fascia Iliaca Compartment Block (FICB) is safe and acceptable. This full trial will test whether it is also more effective and cost-effective than current care. If FICB works, it could transform how hip fracture pain is managed before hospital. Patients would experience less pain during transport and on arrival at the emergency department, with fewer opioid side effects. That could mean faster surgery, shorter hospital stays, and better long-term mobility. The NHS spends £2 billion annually on hip fractures; a cheap, simple injection given at the roadside could reduce that burden. The results are expected to feed directly into national and international clinical guidelines.
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Research question Is Fascia Iliaca Compartment Block (FICB) administered by paramedics in the prehospital setting as pain relief for patients with hip fracture safe, effective and cost-effective? Background Approximately 75,000 people fracture a hip each year in the UK. This excruciatingly painful injury can be devastating – with a high associated mortality rate - and those who survive likely to be more dependent and less mobile than before their injury. Patients with hip fracture occupy 2.5% of all hospital beds at any time and cost the NHS £2 billion each year. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given to patients by paramedics but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes. We have recently completed a feasibility study testing whether paramedic provided FICB is safe and acceptable; whether our trial design worked in the prehospital setting, and whether we could collect data needed in a full trial. This initial study - the RAPID trial (now published) - showed that a full trial is feasible, as assessed against pre-specified progression criteria. Aim To test safety, clinical and cost-effectiveness of paramedic provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment. Methods We will conduct a multi-centre individually randomised parallel-group trial, with a 1:1 allocation ratio between usual care and FICB. Hospital clinicians in five sites (paired ambulance services and receiving hospitals) will train 220 paramedics to administer FICB. We will use individually issued, sequentially numbered scratchcards to conceal randomisation allocation. The primary outcome for this trial is change in pain score from pre-randomisation to arrival at the Emergency Department (ED). We will use the SAIL (Secure Anonymised Information Linkage) databank (in Wales) and NHS Digital (in England) to follow up processes and outcomes using routine anonymised linked data in an efficient study design; and questionnaires to capture patient reported outcomes at 1 and 4 months. 1400 patients are required to find a clinically important difference in primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). Secondary outcomes include mortality; length of stay in hospital; prehospital medications including morphine; presence of hip fracture; satisfaction; mobility; and costs to the NHS. We will assess safety through capture of Serious Adverse Events in each trial arm. Timelines This research will take 5 years and 2 months to prepare, conduct, analyse and report. This includes time to complete ethics and governance processes; train paramedics; recruit patients over 24 months and follow up outcomes. We have included a six month period without cost to allow for the time lag in retrieving routine anonymised outcomes. Public and/or patient members have been involved throughout trial development and we will supplement existing PPI membership across trial management and oversight groups. Impact and dissemination We will disseminate our results widely, using high impact peer-reviewed journals and conferences, in the UK and worldwide. We expect trial findings to be incorporated into relevant national and international practice guidelines.
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