The Randomised Evaluation of early topical Lidocaine patches In Elderly patients admitted to hospital with rib Fractures (RELIEF): Feasibility trial protocol

Lewis, Amanda; Clout, Madeleine; Benger, Jonathan; Braude, Philip; Turner, Nicholas; Gagg, James; Gendall, Emma; Holloway, Simon; Ingram, Jenny; Kandiyali, Rebecca; Maskell, Nick; Shipway, David; Smith, Jason E; Taylor, Jodi; Darweish-Medniuk, Alia; Carlton, Edward

Abstract

BackgroundTopical 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.MethodsRELIEF 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.DiscussionInterventions 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 registrationISRCTN14813929 (22/04/2021).

• Journal Article Type: Article
• Acceptance Date: Sep 5, 2023
• Online Publication Date: Sep 25, 2023
• Publication Date: Sep 25, 2023
• Deposit Date: Nov 10, 2023
• Publicly Available Date: Nov 14, 2023
• Journal: NIHR open research
• Print ISSN: 2633-4402
• Electronic ISSN: 2633-4402
• Publisher: Taylor and Francis
• Peer Reviewed: Peer Reviewed
• Volume: 3
• Article Number: 38
• DOI: https://doi.org/10.3310/nihropenres.13438.2
• Keywords: Feasibility, Frailty, Rib Fractures, Randomised Controlled Trial, Lidocaine Patch
• Public URL: https://uwe-repository.worktribe.com/output/11409245
• PMID: 37881461