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.
Analgesia
Emergency medical services
Fascia iliaca compartment block
Hip fracture
Nerve block
Paramedic
Prehospital
Randomised controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
17 Aug 2022
17 Aug 2022
Historique:
received:
31
05
2022
accepted:
06
07
2022
entrez:
17
8
2022
pubmed:
18
8
2022
medline:
20
8
2022
Statut:
epublish
Résumé
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.
Sections du résumé
BACKGROUND
BACKGROUND
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.
METHODS
METHODS
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).
DISCUSSION
CONCLUSIONS
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.
TRIAL REGISTRATION
BACKGROUND
ISRCTN15831813 . Registered on 22 September 2021.
Identifiants
pubmed: 35978361
doi: 10.1186/s13063-022-06522-3
pii: 10.1186/s13063-022-06522-3
pmc: PMC9385096
doi:
Substances chimiques
Morphine
76I7G6D29C
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
677Subventions
Organisme : Health Technology Assessment Programme
ID : 129972
Informations de copyright
© 2022. The Author(s).
Références
J Orthop Surg (Hong Kong). 2016 Apr;24(1):31-5
pubmed: 27122509
Am J Orthop (Belle Mead NJ). 2014 Jul;43(7):E146-52
pubmed: 25046191
Pilot Feasibility Stud. 2019 Jun 12;5:77
pubmed: 31210961
BMC Med Inform Decis Mak. 2009 Jan 16;9:3
pubmed: 19149883
BMC Health Serv Res. 2006 Apr 19;6:52
pubmed: 16623946
Med Care. 1993 Sep;31(9):834-45
pubmed: 8366685
J Orthop Sci. 2013 Sep;18(5):793-7
pubmed: 23744530
J Bone Joint Surg Am. 2011 Jul 20;93(14):1326-34
pubmed: 21792499
Ann Emerg Med. 2017 Oct;70(4):495-505.e28
pubmed: 28302422
ISRN Orthop. 2014 Mar 04;2014:191306
pubmed: 24977087
Cochrane Database Syst Rev. 2009 Jul 08;(3):MR000008
pubmed: 19588449
J Emerg Med. 2015 May;48(5):581-9
pubmed: 25661312
Emerg Med J. 2012 Jan;29(1):37-9
pubmed: 21362724
Eur J Emerg Med. 2011 Dec;18(6):340-3
pubmed: 21422933
Drugs Aging. 2017 Jan;34(1):1-11
pubmed: 27913981
Med Decis Making. 2013 Aug;33(6):804-18
pubmed: 23633030
Anesthesiology. 2007 Apr;106(4):773-8
pubmed: 17413915
Med Decis Making. 2010 Sep-Oct;30(5):556-65
pubmed: 20228285
BMJ. 2000 Nov 18;321(7271):1247-51
pubmed: 11082083
BMJ Open. 2014 Jan 24;4(1):e003835
pubmed: 24464427
Cost Eff Resour Alloc. 2013 Mar 25;11(1):6
pubmed: 23531194
Medsurg Nurs. 2010 Mar-Apr;19(2):79-83; quiz 84
pubmed: 20476516
Prehosp Emerg Care. 2002 Oct-Dec;6(4):406-10
pubmed: 12385607
Acad Emerg Med. 2013 Aug;20(8):761-8
pubmed: 24033618
Acta Orthop. 2011 Feb;82(1):82-9
pubmed: 21189112
J Emerg Med. 2012 Oct;43(4):692-7
pubmed: 22494596
Anesth Analg. 1989 Dec;69(6):705-13
pubmed: 2589650
Scand J Trauma Resusc Emerg Med. 2014 Jun 23;22:38
pubmed: 24957807
BMJ. 2017 Aug 2;358:j3453
pubmed: 28768629
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Eur J Emerg Med. 2016 Feb;23(1):12-8
pubmed: 24949565
J Bone Joint Surg Br. 2010 Jun;92(6):835-41
pubmed: 20513882
Ann Intern Med. 2011 Aug 16;155(4):234-45
pubmed: 21844549
BMJ Open. 2019 Feb 15;9(2):e026073
pubmed: 30772863
Emerg Med Australas. 2010 Feb;22(1):3-8
pubmed: 20015246
Anaesth Crit Care Pain Med. 2016 Feb;35(1):37-43
pubmed: 26563608
Pharmacoeconomics. 2015 Nov;33(11):1137-54
pubmed: 26040242
Anaesthesia. 2011 Feb;66(2):84-91
pubmed: 21254982
J Emerg Med. 2015 Jan;48(1):85-93
pubmed: 25440868
BMJ Qual Saf. 2019 Sep;28(9):697-705
pubmed: 30397078
Int J Popul Data Sci. 2020 Sep 30;5(3):1363
pubmed: 33644413
BMC Med Ethics. 2019 Nov 27;20(1):88
pubmed: 31775727
J Trauma Acute Care Surg. 2015 Dec;79(6):1067-72; discussion 1072
pubmed: 26680143
J Bone Joint Surg Am. 2005 Mar;87(3):483-9
pubmed: 15741611
Arch Phys Med Rehabil. 2002 Oct;83(10):1442-9
pubmed: 12370883
Pilot Feasibility Stud. 2017 Jan 23;3:8
pubmed: 28163926
West J Emerg Med. 2015 Dec;16(7):1188-93
pubmed: 26759680
Emerg Med (Fremantle). 2002 Sep;14(3):261-6
pubmed: 12487043
Int J Pharm Pract. 2012 Feb;20(1):41-9
pubmed: 22236179
Trials. 2014 May 24;15:189
pubmed: 24885267