Evidence map›Paper›PMID 38760021›Full record

Trial reportEmergency medicine journal : EMJ2024

The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures.

Madeleine Clout, Nicholas Turner, Clare Clement, Philip Braude, Jonathan Benger, James Gagg, Emma Gendall, Simon Holloway, Jenny Ingram, Rebecca Kandiyali and 7 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Emergency medicine journal : EMJ, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Madeleine CloutPopulation Health Sciences, University of Bristol, Bristol, UK.
Nicholas TurnerPopulation Health Sciences, University of Bristol, Bristol, UK.
Clare ClementUniversity of the West of England, Bristol, UK.
Philip BraudeCLARITY (Collaborative Ageing Research), North Bristol NHS Trust, Westbury on Trym, UK.
Jonathan BengerFaculty of Health and Life Sciences, University of the West of England, Bristol, UK.ORCID http://orcid.org/0000-0001-6131-0916
James GaggDepartment of Emergency Medicine, Somerset NHS Foundation Trust, Taunton, UK.
Emma GendallResearch and Innovation, Southmead Hospital, Bristol, UK.
Simon HollowayPharmacy Clinical Trials and Research, Southmead Hospital, Bristol, UK.
Jenny IngramBristol Medical School, University of Bristol, Bristol, UK.
Rebecca KandiyaliWarwick Clinical Trials Unit, Warwick Medical School, Coventry, UK.
Amanda LewisPopulation Health Sciences, University of Bristol, Bristol, UK.
Nick A MaskellAcademic Respiratory Unit, University of Bristol, Bristol, UK.
David ShipwayDepartment of Medicine for Older People, Southmead Hospital, North Bristol NHS Trust, Bristol, UK.
Jason E SmithEmergency Department, University Hospitals Plymouth NHS Trust, Plymouth, UK.ORCID http://orcid.org/0000-0002-6143-0421
Jodi TaylorBristol Trials Centre, Population Health Sciences, University of Bristol, Bristol, UK.
Alia Darweish MedniukDepartment of Anaesthesia and Pain Medicine, Southmead Hospital, Bristol, UK.
Edward CarltonEmergency Department, Southmead Hospital, Bristol, UK eddcarlton@gmail.com.ORCID http://orcid.org/0000-0002-2064-4618

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible.

methodsThis was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes.

resultsBetween October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures.

conclusionRecruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial. TRIAL REGISTRATION NUMBER: ISRCTN14813929.

Indexed as

Anesthetics, LocalLidocaineRib FracturesAgedAged, 80 and overEmergency Service, HospitalEnglandFeasibility StudiesFemaleHumansMaleScotlandSurveys and QuestionnairesTransdermal PatchAnesthetics, LocalLidocainechestfeasibility studiesfrail elderlygeriatricslocal

Identifiers

PMID38760021
PMCPMC11347219

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.