RELIEF Feasibility Trial
Research type
Research Study
Full title
The Randomised Evaluation of early topical Lidocaine patches in Elderly patients admitted to hospital with rib Fractures (RELIEF): feasibility trial
IRAS ID
285096
Contact name
Edward Carlton
Contact email
Sponsor organisation
North Bristol NHS Trust, Research and Innovation
ISRCTN Number
ISRCTN14813929
Duration of Study in the UK
2 years, 2 months, 31 days
Research summary
We know that pain from broken ribs can be severe. Currently, to control the pain, strong pain killers, like morphine, are often used. These can cause side-effects like constipation and confusion in older people. We 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. Older people are likely to benefit most from these patches but there is no research to support this.
In this small study we hope to find out whether a larger study 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 are looking for about 100 older people (aged 65 years or older) in the Emergency Department, who are found to have broken ribs, and who need admission to a hospital ward.
Participants will be allocated to one of two treatment groups through a process called randomisation (i.e. they will have an equal chance of receiving either treatment); half of the participants will be in one group and half in the other. In one group, patients will have pain killers (like paracetamol and/or morphine) prescribed in the usual way and their usual treatment will not change.In the other group, patients will have pain killers (like paracetamol and/or morphine) prescribed in the usual way. In addition, they will have a patch containing numbing medication placed over their broken ribs. This treatment will start in the Emergency Department and last for 3-days, or until they are discharged from hospital, whichever is sooner.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
21/SC/0019
Date of REC Opinion
30 Mar 2021
REC opinion
Further Information Favourable Opinion