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

ABSTRACT

BACKGROUND AND AIMS: Patches containing a numbing medication (lidocaine), put on the skin over broken ribs, may help to improve outcomes in older people. We will carry out a clinical trial of these patches, to see whether this research would work in Accident and Emergency (A&E) and whether patients will take part. DESIGN: We will ask 100 older people who need to stay in hospital with broken ribs to take part in this research. We will ask permission from relatives to include people with dementia. We will put those who agree to take part into one of two groups by chance. One group will have the patch put over their broken ribs in A&E for up to 3 days, along with usual pain killers if needed. We will treat people in the other group in the normal way, without a patch. We will track how many people are willing to take part. We will collect information on patient recovery in the 30 days after going to A&E and ask people to complete questionnaires about their health. We will interview patients and clinicians to get feedback. Patient and Public Involvement: Patient volunteers helped us design this research and will provide advice throughout. They agreed that including older people was appropriate, people with dementia and their carers should take part, and side-effects of strong pain killers are important to patients. FINDINGS: We will use the research findings to develop a larger trial to see if lidocaine patches help patients with broken ribs. We will write up results for scientific journals, speak at conferences and to our patient group.