Title

Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency hip fracture care Delivery (RAPID 2)

Principal / Lead Investigator
Co-Investigators / Research Team
Type of study

Randomised controlled trial

Summary

Background and study aims
Hip fractures are a very common injury for elderly people. About one in three patients who break their hip die within one year and many patients lose mobility and independence. Pain relief before the patient reaches hospital is often inadequate and causes side effects which may slow down recovery. We have recently completed a small study testing whether a local anaesthetic injection into the hip area called Fascia Iliaca Compartment Block (FICB) given by paramedics at the scene of injury is safe and acceptable. We met all the criteria that we set at the beginning of the study, and concluded that it is feasible to undertake a full trial.

Aim
We aim to find out whether the local anaesthetic injection reduces pain, is safe, and improves patient health outcomes, as well as how much it costs the National Health Service (NHS).

Who can participate?
Adult patients attended by a participating study paramedic following a 999 call who are assessed as having an isolated hip fracture.

What does the study involve?
We will carry out a trial where paramedics give patients either the new treatment - local anaesthetic injection or usual care (often morphine). Patients will be allocated to one or other treatment by a random process (similar to tossing a coin) to ensure a fair comparison between treatments. We will provide training for the paramedics who take part in the trial, so that they can perform the local anaesthetic injection safely. When a trained paramedic attends a patient he or she assesses as having a hip fracture, (s)he will use a scratchcard to decide which treatment to give the patient. We will compare patients’ pain levels, other outcomes and costs between those allocated to the new local anaesthetic injection and those allocated to receive usual care. The other outcomes we will compare between the two groups during their initial care and up to four months following injury are: length of stay in hospital, deaths, quality of life, ability to walk, and satisfaction with care. We will also monitor safety by identifying any concerning health-related events in each group. We will work out the costs of NHS care in each group.

Lay involvement

Two members of the public have helped us to plan this bid and two patient groups (approximately 40 individuals) reviewed our ideas. Members of the public will continue to be involved throughout this research. During the research, members of the public will attend meetings, help to write information sheets for patients, and help to write up the findings from this research. Members of the public will also sit on our oversight committee to ensure the research is carried out properly, and be part of local implementation teams at sites to ensure the patient voice is heard throughout our research.

How can this research potentially benefit patients?

The possible benefits of taking part are potentially receiving more effective pain relief at the time of hip fracture. The risks of taking part - there are some potential complications of the local anaesthetic nerve block, including infection or bruising at the site of the injection. Rarer complications include nerve damage and local anaesthetic toxicity. Although there are potential complications, current usual care (morphine) also has several known side effects including confusion, nausea, constipation and respiratory depression - the patient will avoid these side effects.

Funder

NIHR HTA

Total grant value

£ 1,818,109

Amount to Wales

To follow

Start date

01/12/2020

End date

31/01/2025

Outputs generated
Related links