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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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DOI (Published version): 10.1186/s13063-022-06522-3

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
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URI: https://cronfa.swan.ac.uk/Record/cronfa60991
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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&#x2009;~&#x2009;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&#xA0;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: &#xA9; 2022. The Author(s).]</abstract><type>Journal Article</type><journal>Trials</journal><volume>23</volume><journalNumber>1</journalNumber><paginationStart>677</paginationStart><paginationEnd/><publisher>Springer Science and Business Media LLC</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint/><issnElectronic>1745-6215</issnElectronic><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</keywords><publishedDay>17</publishedDay><publishedMonth>8</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-08-17</publishedDate><doi>10.1186/s13063-022-06522-3</doi><url/><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm/><funders>This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (award number 129972).</funders><projectreference/><lastEdited>2022-08-31T15:37:36.3842400</lastEdited><Created>2022-08-31T15:12:36.3464209</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Mark</firstname><surname>Kingston</surname><orcid>0000-0003-2242-4210</orcid><order>1</order></author><author><firstname>Jenna</firstname><surname>Jones</surname><order>2</order></author><author><firstname>Sarah</firstname><surname>Black</surname><order>3</order></author><author><firstname>Bridie</firstname><surname>Evans</surname><orcid>0000-0003-0293-0888</orcid><order>4</order></author><author><firstname>Simon</firstname><surname>Ford</surname><order>5</order></author><author><firstname>Theresa</firstname><surname>Foster</surname><order>6</order></author><author><firstname>Steve</firstname><surname>Goodacre</surname><order>7</order></author><author><firstname>Marie-Louise</firstname><surname>Jones</surname><order>8</order></author><author><firstname>Sian</firstname><surname>Jones</surname><order>9</order></author><author><firstname>Leigh</firstname><surname>Keen</surname><order>10</order></author><author><firstname>Mirella</firstname><surname>Longo</surname><order>11</order></author><author><firstname>Ronan</firstname><surname>Lyons</surname><orcid>0000-0001-5225-000X</orcid><order>12</order></author><author><firstname>Ian</firstname><surname>Pallister</surname><order>13</order></author><author><firstname>Nigel</firstname><surname>Rees</surname><order>14</order></author><author><firstname>Aloysius Niroshan</firstname><surname>Siriwardena</surname><order>15</order></author><author><firstname>Alan</firstname><surname>Watkins</surname><orcid>0000-0003-3804-1943</orcid><order>16</order></author><author><firstname>Julia</firstname><surname>Williams</surname><order>17</order></author><author><firstname>Helen</firstname><surname>Wilson</surname><order>18</order></author><author><firstname>Helen</firstname><surname>Snooks</surname><orcid>0000-0003-0173-8843</orcid><order>19</order></author></authors><documents><document><filename>60991__25058__1b5a0b315d3c4d5ea5efed017eb72898.pdf</filename><originalFilename>60991_VoR.pdf</originalFilename><uploaded>2022-08-31T15:35:47.1053615</uploaded><type>Output</type><contentLength>2632881</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; The Author(s) 2022. 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spelling 2022-08-31T15:37:36.3842400 v2 60991 2022-08-31 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 3442763d6ff0467963e0792d2b5404fa 0000-0003-2242-4210 Mark Kingston Mark Kingston true false e662b6c5aba239a9cd0f115d16df0a82 Jenna Jones Jenna Jones true false 6098eddc58e31ac2f3e070cb839faa6a 0000-0003-0293-0888 Bridie Evans Bridie Evans true false 83efcf2a9dfcf8b55586999d3d152ac6 0000-0001-5225-000X Ronan Lyons Ronan Lyons true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false ab23c5e0111b88427a155a1f495861d9 0000-0003-0173-8843 Helen Snooks Helen Snooks true false 2022-08-31 HDAT 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).] Journal Article Trials 23 1 677 Springer Science and Business Media LLC 1745-6215 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 17 8 2022 2022-08-17 10.1186/s13063-022-06522-3 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University This study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (award number 129972). 2022-08-31T15:37:36.3842400 2022-08-31T15:12:36.3464209 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Mark Kingston 0000-0003-2242-4210 1 Jenna Jones 2 Sarah Black 3 Bridie Evans 0000-0003-0293-0888 4 Simon Ford 5 Theresa Foster 6 Steve Goodacre 7 Marie-Louise Jones 8 Sian Jones 9 Leigh Keen 10 Mirella Longo 11 Ronan Lyons 0000-0001-5225-000X 12 Ian Pallister 13 Nigel Rees 14 Aloysius Niroshan Siriwardena 15 Alan Watkins 0000-0003-3804-1943 16 Julia Williams 17 Helen Wilson 18 Helen Snooks 0000-0003-0173-8843 19 60991__25058__1b5a0b315d3c4d5ea5efed017eb72898.pdf 60991_VoR.pdf 2022-08-31T15:35:47.1053615 Output 2632881 application/pdf Version of Record true © The Author(s) 2022. This article is licensed under a Creative Commons Attribution 4.0 International License true eng http://creativecommons.org/licenses/by/4.0/
title 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
spellingShingle 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
Jenna Jones
Bridie Evans
Ronan Lyons
Alan Watkins
Helen Snooks
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author_id_str_mv 3442763d6ff0467963e0792d2b5404fa
e662b6c5aba239a9cd0f115d16df0a82
6098eddc58e31ac2f3e070cb839faa6a
83efcf2a9dfcf8b55586999d3d152ac6
81fc05c9333d9df41b041157437bcc2f
ab23c5e0111b88427a155a1f495861d9
author_id_fullname_str_mv 3442763d6ff0467963e0792d2b5404fa_***_Mark Kingston
e662b6c5aba239a9cd0f115d16df0a82_***_Jenna Jones
6098eddc58e31ac2f3e070cb839faa6a_***_Bridie Evans
83efcf2a9dfcf8b55586999d3d152ac6_***_Ronan Lyons
81fc05c9333d9df41b041157437bcc2f_***_Alan Watkins
ab23c5e0111b88427a155a1f495861d9_***_Helen Snooks
author Mark Kingston
Jenna Jones
Bridie Evans
Ronan Lyons
Alan Watkins
Helen Snooks
author2 Mark Kingston
Jenna Jones
Sarah Black
Bridie Evans
Simon Ford
Theresa Foster
Steve Goodacre
Marie-Louise Jones
Sian Jones
Leigh Keen
Mirella Longo
Ronan Lyons
Ian Pallister
Nigel Rees
Aloysius Niroshan Siriwardena
Alan Watkins
Julia Williams
Helen Wilson
Helen Snooks
format Journal article
container_title Trials
container_volume 23
container_issue 1
container_start_page 677
publishDate 2022
institution Swansea University
issn 1745-6215
doi_str_mv 10.1186/s13063-022-06522-3
publisher Springer Science and Business Media LLC
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description 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).]
published_date 2022-08-17T04:19:33Z
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