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Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)—protocol for an individually randomised parallel-group trial

Mark Kingston Orcid Logo, Jenna Jones, Sarah Black, Bridie Evans Orcid Logo, Simon Ford, Theresa Foster, Steve Goodacre, Marie-Louise Jones, Sian Jones, Leigh Keen, Mirella Longo, Ronan Lyons Orcid Logo, Ian Pallister, Nigel Rees, Aloysius Niroshan Siriwardena, Alan Watkins Orcid Logo, Julia Williams, Helen Wilson, Helen Snooks Orcid Logo

Trials, Volume: 23, Issue: 1, Start page: 677

Swansea University Authors: Mark Kingston Orcid Logo, Jenna Jones, Bridie Evans Orcid Logo, Ronan Lyons Orcid Logo, Alan Watkins Orcid Logo, Helen Snooks Orcid Logo

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Abstract

Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given...

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Published in: Trials
ISSN: 1745-6215
Published: Springer Science and Business Media LLC 2022
Online Access: Check full text

URI: https://cronfa.swan.ac.uk/Record/cronfa60991
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Abstract: Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given 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 completed a feasibility study of paramedic-provided fascia iliaca compartment block (FICB), testing the intervention, trial methods and data collection. The study (RAPID) demonstrated that a full trial was feasible. In this subsequent study, we 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. We will conduct a pragmatic multi-centre individually randomised parallel-group trial, with a 1:1 allocation between usual care (control) and FICB (intervention). Hospital clinicians in five sites (paired ambulance services and receiving hospitals) in England and Wales will train 220 paramedics to administer FICB. The primary outcome is change in pain score from pre-randomisation to arrival at the emergency department. One thousand four hundred patients are required to find a clinically important difference between trial arms in the primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). We will use NHS Digital (England) and the SAIL (Secure Anonymised Information Linkage) databank (Wales) to follow up patient outcomes using routine anonymised linked data in an efficient study design, and questionnaires to capture patient-reported outcomes at 1 and 4 months. Secondary outcomes include mortality, length of hospital stay, job cycle time, prehospital medications including morphine, presence of hip fracture, satisfaction, mobility, and NHS costs. We will assess safety by monitoring serious adverse events (SAEs). The trial will help to determine whether paramedic administered FICB is a safe, clinically and cost-effective treatment for suspected hip fracture in the pre-hospital setting. Impact will be shown if and when clinical guidelines either recommend or reject the use of FICB in routine practice in this context. ISRCTN15831813 . Registered on 22 September 2021. [Abstract copyright: © 2022. The Author(s).]
Keywords: Cost-Benefit Analysis, Allied Health Personnel, Prehospital, Emergency medical services, Fascia iliaca compartment block, Paramedic, Randomised controlled trial, Nerve block, Hip Fractures - surgery, Nerve Block - adverse effects - methods, Randomized Controlled Trials as Topic, Morphine - adverse effects, Humans, Hip fracture, Pain - drug therapy, Multicenter Studies as Topic, Analgesia - methods, Analgesia, Fascia
College: Swansea University Medical School
Funders: This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (award number 129972).
Issue: 1
Start Page: 677