The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved]
Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved...
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| Format: | Article |
| Language: | English |
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F1000 Research Ltd
2023-09-01
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| Series: | NIHR Open Research |
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| Online Access: | https://openresearch.nihr.ac.uk/articles/3-38/v2 |
| _version_ | 1797665446776799232 |
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| author | Jason E Smith David Shipway Alia Darweish-Medniuk Jodi Taylor Edward Carlton Amanda Lewis Jonathan Benger Madeleine Clout Nicholas Turner Philip Braude Emma Gendall James Gagg Jenny Ingram Simon Holloway Nick Maskell Rebecca Kandiyali |
| author_facet | Jason E Smith David Shipway Alia Darweish-Medniuk Jodi Taylor Edward Carlton Amanda Lewis Jonathan Benger Madeleine Clout Nicholas Turner Philip Braude Emma Gendall James Gagg Jenny Ingram Simon Holloway Nick Maskell Rebecca Kandiyali |
| author_sort | Jason E Smith |
| collection | DOAJ |
| description | Background: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible. Methods: RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed. Discussion: Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible. ISRCTN Registration: ISRCTN14813929 (22/04/2021). |
| first_indexed | 2024-03-11T19:45:02Z |
| format | Article |
| id | doaj.art-fa8a7108f83249eb9e4b4d6c90eb91b6 |
| institution | Directory Open Access Journal |
| issn | 2633-4402 |
| language | English |
| last_indexed | 2024-03-11T19:45:02Z |
| publishDate | 2023-09-01 |
| publisher | F1000 Research Ltd |
| record_format | Article |
| series | NIHR Open Research |
| spelling | doaj.art-fa8a7108f83249eb9e4b4d6c90eb91b62023-10-06T00:00:00ZengF1000 Research LtdNIHR Open Research2633-44022023-09-01314641The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved]Jason E Smith0https://orcid.org/0000-0002-6143-0421David Shipway1https://orcid.org/0000-0001-9771-5878Alia Darweish-Medniuk2Jodi Taylor3Edward Carlton4Amanda Lewis5Jonathan Benger6https://orcid.org/0000-0001-6131-0916Madeleine Clout7https://orcid.org/0000-0001-7645-1199Nicholas Turner8Philip Braude9Emma Gendall10James Gagg11https://orcid.org/0000-0002-9472-6376Jenny Ingram12Simon Holloway13Nick Maskell14Rebecca Kandiyali15Emergency Department, Derriford Hospital, University Hospitals Plymouth NHS Trust, Plymouth, UKDepartment of Elderly Care Medicine, Southmead Hospital, North Bristol NHS Trust, Bristol, England, UKDepartment of Anaesthesia and Pain Medicine, Southmead Hospital, North Bristol NHS Trust, Bristol, England, UKBristol Trials Centre (BTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKDepartment of Emergency Medicine, Southmead Hospital, North Bristol NHS Trust, Bristol, England, UKBristol Trials Centre (BTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKEmergency Care, Faculty of Health and Applied Sciences, University of the West of England, Bristol, England, UKBristol Trials Centre (BTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKBristol Trials Centre (BTC), Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKDepartment of Elderly Care Medicine, Southmead Hospital, North Bristol NHS Trust, Bristol, England, UKResearch and Innovation, Southmead Hospital, North Bristol NHS Trust, Bristol, England, UKDepartment of Emergency Medicine, Musgrove Park Hospital, Taunton, England, UKPopulation Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKPharmacy Clinical Trials and Research, Southmead Hospital, North Bristol NHS Trust, Bristol, England, UKAcademic Respiratory Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, England, UKWarwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Warwick, England, UKBackground: Topical lidocaine patches, applied over rib fractures, have been suggested as a non-invasive method of local anaesthetic delivery to improve respiratory function, reduce opioid consumption and consequently reduce pulmonary complications. Older patients may gain most benefit from improved analgesic regimens yet lidocaine patches are untested as an early intervention in the Emergency Department (ED). The aim of this trial is to investigate uncertainties around trial design and conduct, to establish whether a definitive randomised trial of topical lidocaine patches in older patients with rib fractures is feasible. Methods: RELIEF is an open label, multicentre, parallel group, individually randomised, feasibility randomised controlled trial with economic scoping and nested qualitative study. Patients aged ≥ 65 years presenting to the ED with traumatic rib fracture(s) requiring admission will be randomised 1:1 to lidocaine patches (intervention), in addition to standard clinical management, or standard clinical management alone. Lidocaine patches will be applied immediately after diagnosis in ED and continued daily for 72 hours or until discharge. Feasibility outcomes will focus on recruitment, adherence and follow-up data with a total sample size of 100. Clinical outcomes, such as 30-day pulmonary complications, and resource use will be collected to understand feasibility of data collection. Qualitative interviews will explore details of the trial design, trial acceptability and recruitment processes. An evaluation of the feasibility of measuring health economics outcomes data will be completed. Discussion: Interventions to improve outcomes in elderly patients with rib fractures are urgently required. This feasibility trial will test a novel early intervention which has the potential of fulfilling this unmet need. The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF) feasibility trial will determine whether a definitive trial is feasible. ISRCTN Registration: ISRCTN14813929 (22/04/2021).https://openresearch.nihr.ac.uk/articles/3-38/v2Randomised Controlled Trial Feasibility Lidocaine patch Rib fractures Frailtyeng |
| spellingShingle | Jason E Smith David Shipway Alia Darweish-Medniuk Jodi Taylor Edward Carlton Amanda Lewis Jonathan Benger Madeleine Clout Nicholas Turner Philip Braude Emma Gendall James Gagg Jenny Ingram Simon Holloway Nick Maskell Rebecca Kandiyali The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved] NIHR Open Research Randomised Controlled Trial Feasibility Lidocaine patch Rib fractures Frailty eng |
| title | The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved] |
| title_full | The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved] |
| title_fullStr | The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved] |
| title_full_unstemmed | The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved] |
| title_short | The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial protocol [version 2; peer review: 2 approved] |
| title_sort | randomised evaluation of early topical lidocaine patches in elderly patients admitted to hospital with rib fractures relief feasibility trial protocol version 2 peer review 2 approved |
| topic | Randomised Controlled Trial Feasibility Lidocaine patch Rib fractures Frailty eng |
| url | https://openresearch.nihr.ac.uk/articles/3-38/v2 |
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