Condition category
Musculoskeletal Diseases
Date applied
05/11/2015
Date assigned
11/11/2015
Last edited
30/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Breaking a hip is very painful. Patients who break their hip will often call 999 and be taken to hospital by an ambulance. Sadly, research has shown that paramedics do not always give patients with a broken hip adequate pain relief. Fascia iliaca compartment block (FICB) has been tested in a few small studies recently. It has been shown to be a safe and effective method of giving pain relief to patients with hip fracture. FICB involves finding a soft tissue ‘compartment’ which lies over the hip. This is done using bony landmarks and feeling resistance from a needle. The person giving the FICB will feel two 'pops' as the needle goes through two tissue layers (fascias). Local anaesthetic is then injected into this ‘compartment’ with the aim of blocking sensation to three nerves in this area (femoral, obturator, lateral femoral cutaneous). The patient will then not be able to feel pain from their hip. This study involves paramedics giving FICB to some patients who break their hip. It is possible that FICB could give better pain relief to patients who break their hip than what patients are given in current practice (usually morphine). FICB could also reduce the amount of morphine given to patients who break their hip. This would benefit patients because morphine has several side effects (feeling sick, giddy or confused, being constipated or having trouble breathing). This study will also investigate whether FICB has any long term benefits by comparing death rates, general health and mobility of patients 30 days after the injury. It will also look at whether it would be possible and worthwhile to carry out a bigger trial involving a number of trial participating centres.

Who can participate?
Adult patients assessed by a paramedic as having a hip fracture.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given standard pain relief (usually morphine). Those in group 2 are given FICB. If the FICB does not work within 15-20 minutes, they may also be given morphine. All participants can be given paracetamol and Entonox (other types of painkillers) as required. Once they reach the hospital, a nurse asks them to assess their pain levels by giving a score between 0 (no pain) to 10 (worst pain imaginable). All patients are then followed up 30 days later to record the number of people who have died, their general state of health and how mobile they now are after the fracture.

What are the possible benefits and risks of participating?
Trial participants who receive the local anaesthetic injection instead of morphine may benefit from superior pain relief or better long term outcomes as a result of taking part in the trial, but we do not know for sure – that is why we are carrying out this research. There are risks of having a local anaesthetic injection such as nerve damage (short term or long term) and bleeding, which are rare. A more common side effect is bruising around the site of the injection.

Where is the study run from?
Swansea University (Wales, UK)

When is the study starting and how long is it expected to run for?
October 2015 to September 2017

Who is funding the study?
Health and Care Research Wales

Who is the main contact?
Dr Jenna Bulger

Trial website

Contact information

Type

Public

Primary contact

Dr Jenna Bulger

ORCID ID

Contact details

ILS2
Singleton Campus
Swansea University
Swansea
SA2 8PP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

Rapid Analgesia for Prehospital Hip Disruption (RAPID): a feasibility study for a randomised controlled trial

Acronym

RAPID

Study hypothesis

We hypothesise that it is feasible to undertake a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics providing FICB ( fascia iliaca compartment block) as early pain relief to patients who have fractured a hip at the scene of their injury.

Ethics approval

Wales REC 6, 07/01/2016, ref: 15/WA/0439

Study design

Feasibility study for a randomised controlled trial, conducted in a single site

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Patients with hip fracture, in the prehospital environment

Intervention

Participants are randomly allocated to one of two groups.
1. Group 1: Patients receive standard treatment and given normal pain relief (usually morphine)
2. Group 2: Patients receive fascia iliaca compartment block (FICB). If the FICB has not relieved the patient's pain after 15-20 minutes, the paramedic will also be able to give them morphine.
Patients in both groups can be given paracetamol and Entonox as required, as is current practice. A pain score will be taken by the triage nurse when the patient arrives at the emergency department. The patients will then be followed up at 30 days to record death rates, health status and patient mobility.

Training will be provided for the paramedics taking part in the trial, so that they can perform the FICB safely and appropriately. This will involve:
1. E-learning
2. Group teaching sessions
3. Attending the local hospital in pairs to perform FICB on patients who require them (under the supervision of an anaesthetist).
The paramedics will identify patients with suspected hip fractures. The patient will be asked to give a pain score on a scale from zero to ten. Zero is no pain at all and ten is the worst pain ever. For patients who cannot express their pain score due to disability or dementia, a different pain score will be used (the Adapted Abbey Scale). The paramedic will then open a sealed opaque envelope containing a computer generated random number. This will decide whether the patient is given intervention or control treatment.

There will also be interviews with patients and focus groups with paramedics to find out whether FICB is acceptable to paramedics who are performing it, and to patients who are receiving it.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Our feasibility study objectives are as follows: to assess
1. Accuracy, in particular specificity, of recognition of hip fracture by paramedics in order to establish appropriate and safe delivery of the intervention.
2. Willingness of both patients and paramedics to participate in the study.
3. Compliance with the intervention by paramedics.
4. Sample size required for a full RCT, and recruitment period required to achieve target.
5. Acceptability of the method of providing pain relief in the prehospital care of patients with hip fracture.
6. Which outcome measures should be used in a full RCT and at what point they should be recorded. Proposed outcomes measures to be tested are:
6.1. Self-reported pain level using numeric rating scale of 0- 10 with 0 being no pain at all and 10 being the worst pain imaginable. This will be recorded immediately before pain relief is given and repeated on arrival at the hospital by the triage nurse (before they know which pain relief the patient received).
6.2. Patient satisfaction with the care they received from paramedics using a modified Quality of Care Monitor. This will be measured when the NHS researcher takes consent to participate in the trial at approximately 7-10 days after the patient's injury
6.3. Complications of FICB (Patient safety – adverse events (AE) and serious adverse events (SAE) will be recorded)
6.4. Length of time that the paramedics were with the patient (in order to determine whether providing FICB has a significant effect of delaying the paramedics)
6.5. Requirement of antiemetics and alternative analgesia
6.6. Length of stay
6.7. Mortality at 30 days and/or at six months
6.8. Time from admission to surgery
6.9. Health related quality of life, using SF12 at 30 days and/or at six months
6.10. Mobility score, using the Rivermead index at 30 days and/or at six months
7. Whether or not it is feasible and warranted to carry out a full, multi-centre trial, as indicated by our progression criteria, all of which must be met within reasonable limits:
7.1. Paramedic recognition of hip fractures have a sensitivity of 60% or more and a specificity of 90% of more
7.2. Ability to recruit ten paramedics to the trial
7.3. 80% or more of eligible patients consent to treatment in the intervention arm
7.4. Consent to follow up 60% or more
7.5. Follow up data for primary outcomes can be collected for 70% or more of patients
7.6. Mean patient satisfaction in intervention group is not less than 80% of patient satisfaction in the control group
7.7. Feasibility trial findings indicate that we remain in equipoise about the effectiveness of paramedic administered FICB (i.e. that pain scores before pain relief and on arrival at hospital has a difference of less than 50% between intervention and control groups)
7.8. Adverse event rate (e.g. arterial puncture or infection at the site of FICB) of less than 5%

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2015

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or over
2. Patients who are assessed by a paramedic as having a hip fracture (paramedics will make this assessment by using a hip fracture diagnosis checklist tool)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patient refuses to participate
2. Patient is combative
3. Patient has an allergy to local anaesthetic
4. Patient is receiving coagulopathy (use of warfarin, clopidogrel or ‘new’ anticoagulants)
5. Patient has any other distracting injury (i.e. has pain in a different place, which would make taking pain scores for only the hip difficult)
6. Patient has decreased level of consciousness (Glasgow Coma Scale score of less than 14)
7. Patient is haemodynamically unstable
8. Patient has neurovascular damage to the affected leg
9. Patient has received previous femoral bypass surgery
10. Patient has an infection at the site of insertion of the injection
11. The paramedic is unable to palpate the femoral artery on the affected leg
12. Patients who appear to have body mass of less than 50kg (A 50kg patient could safely be given 6ml/kg of 1% prilocaine. By only using 30ml of the local anaesthetic, we will have a margin of safety to avoid patients developing local anaesthetic toxicity).

Recruitment start date

01/05/2016

Recruitment end date

30/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Swansea University
ILS2, Singleton Campus Swansea
Wales
SA2 8PP
United Kingdom

Sponsor information

Organisation

Welsh Ambulance Services NHS Trust

Sponsor details

Pre-hospital Emergency Research Unit
Lansdowne Hospital
Sanatorium Road
Cardiff
CF11 8UL
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Health and Care Research Wales

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of trial protocol, a paper about training paramedics to provide FICB in the emergency prehospital environment and a qualitative and quantitative results paper.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.