Title: The Randomised Evaluation of early topical Lidocaine patches in Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial.
Funder: Department of Health and Social Care

Abstract: Research question Is it feasible to conduct a multi-centre randomised controlled trial (RCT) to evaluate the use of topical lidocaine patches in older hospitalised patients with rib fractures? Background We have worked with clinical experts and patient groups across the Severn Major Trauma Network to identify an early non-invasive, non-opioid analgesic option for older patients with traumatic rib fractures. Topical lidocaine patches have the potential to reduce pulmonary complications and side effects of current analgesic regimens, which rely on strong opioid analgesia, in this vulnerable patient group. Over 15% of these patients suffer pulmonary complications, with pain compromising respiratory function, therefore improved analgesic modalities are urgently required to improve outcomes. However, there are currently no trial data to support lidocaine patch use in older patients. Building on prior experience in running pragmatic RCTs in emergency care, we have developed a feasibility trial, evaluating topical lidocaine patches, to inform acceptability, recruitment and retention strategies and to confirm appropriateness of clinical outcome measures of a definitive trial. Aim: To investigate the uncertainties around trial design and conduct to establish whether a definitive trial is feasible and to optimise the design of such a trial. Methods Prospective, pragmatic, single-blinded multicentre feasibility RCT across three sites: Bristol, Taunton and Plymouth. We will enrol 100 adult patients (age 65 years) with traumatic rib fracture(s) requiring hospital admission. Patients will be randomized 1:1- to either lidocaine patch therapy or standard clinical management immediately after diagnosis in the Emergency Department. Patients in the intervention group will have 700mg lidocaine patch(es) placed directly over the rib fracture(s). Patch treatment will continue for up to 72 hours. The intervention is additive to standard clinical management. Standard clinical management will be the local analgesic protocols in use for patients with rib fractures. Outcomes Feasibility outcomes: (a) the number of eligible patients approached. (b) the proportion of approached patients randomised. (c) attrition. (d) the proportion of recruited patients for which the primary outcome is available and completeness of each secondary outcome measure. (e) acceptability of the trial processes to clinicians and participants through qualitative interviews. (f) acceptability of outcome measures to patients from interviews. (g) adherence to the intervention. Clinical Outcomes: Clinical data will be collected on primary and secondary outcomes proposed for the main trial: Primary Outcome: 30-day Pulmonary complications (chest infection, pneumonia, pleural effusion, empyema, need for ventilatory support and death secondary to a pulmonary cause) Secondary Outcomes: Incidence of frailty syndromes occurring during hospital admission All-cause mortality Intensive Care admission Total length of hospital stay Total opioid consumption in first 72 hoursTimelines for delivery Duration 36 months, with 18-month recruitment period Impact and Dissemination An early, non-invasive, non-opioid analgesic option for pain relief in rib fractures which improves patient outcomes would have a profound effect on patients and the NHS. The study protocol and results will be published in specialty journals and presented at conferences. Results will inform the development of an NIHR HTA bid for a definitive trial by 2023.

Lay abstract: Background We know that older people who injure themselves are vulnerable. Our experience in looking after them and working with patient groups tells us that we need to test potential new treatments for these patients. Over 20,000 older patients are admitted to hospital each year after injuring themselves. We know that broken ribs are one of the commonest injuries. Many older people with broken ribs go on to suffer breathing problems. Pain reduces chest movements which can lead to chest infections. Currently, to control the pain from broken ribs, strong pain killers, like morphine, are often used. These can cause side-effects like constipation and confusion in older people. We have worked with expert doctors and have identified that a patch containing a numbing medication (anaesthetic) called lidocaine, put on the skin over the broken ribs very soon after injury, may help to control pain and improve breathing with fewer side effects. Lidocaine patches have been shown to be very safe and some specialist pain doctors already use them. Older people are likely to benefit most from these patches but there is no research to support this. I have put together a team of experts and built upon my previous experience in carrying out research in an emergency setting to come up with this trial. Aims We will carry out a study using lidocaine patches for older patients in the Emergency Department who are found to have broken ribs, and who need admission to a hospital ward. It will pave the way for a larger trial by looking at the way the study works. It will also explore whether using the patches could potentially lead to fewer breathing problems and fewer side-effects from strong painkillers. Design and Methods 100 older (over 65 years) patients with broken ribs admitted to three hospitals in Bristol, Taunton and Plymouth will be included in the study. Patients will be put into one of two groups by chance. One group will have the patch containing the numbing medication put over their broken ribs. This treatment will be started in the Emergency Department and will last for 3 days. The other group will be treated in the normal way without a patch. All patients will be given some painkillers to make them comfortable as well as the patch. We will investigate whether a larger trial could work by seeing how many patients are willing to take part and whether the information we collect is complete. We will also see if patients get chest infections or medication side-effects in the 30 days after injury to see whether the patches could help. We will invite 24 patients (and some of their carers) to be interviewed to find out what it was like to be in the trial. All this information will help us see if a larger trial will be possible, whether it is acceptable to patients and whether the patches might improve care. Patient and Public Involvement Patient volunteers have helped us shape the design of this research. They agreed that including patients over 65 years old was appropriate, that patients with early dementia and their carers should be included, and that medication side-effects like constipation are important. Our Patient Advisory Group will continue to help us during the Fellowship and will ensure the research is acceptable to patients. Dissemination Findings will be used to develop a larger study to see if lidocaine patches help patients with broken ribs. Results will be written-up in scientific journals and we will speak at conferences. Patients will be told about the study through newsletters distributed through charities, social and traditional media.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INJURIES AND ACCIDENTS