Elderly patients admitted to hospital with rib fractures Injury, Occupational Diseases, Poisoning Fracture of rib(s), sternum and thoracic spine
Conditions
Interventions
Patients will be randomised on a 1:1 ratio to either the lidocaine patch (intervention) or standard care (control) group immediately after diagnosis in the Emergency Department and written consent is
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Potential participants must satisfy the following criteria to be enrolled in this study: 1. Older adult patients (age =65 years) 2. Presenting to the ED with traumatic rib fracture(s) (including multiple fractures, flail chest and traumatic haemo/pneumothorax even if this requires intercostal chest drainage), confirmed radiologically (by chest X-Ray or CT scan conducted as part of routine care) 3. Requiring hospital admission for ongoing care
Exclusion criteria
Exclusion criteria: Potential participants who meet any of the following criteria will be excluded from participation: 1. Serious distracting trauma to other body regions (adjudicated by the treating clinician): examples include but may not be limited to: traumatic brain injury with cognitive impairment, acute spinal column fracture or spinal cord injury, abdominal and lower limb injuries requiring surgery, unstable pelvic fracture 2. Requirement for intubation and mechanical ventilation either prehospitally or in the ED 3. History of allergy to lidocaine 4. Open wounds at the site of patch application 5. End-stage dementia (adjudicated by the treating clinician, e.g. bed-bound and non-verbal); patients with mild to moderate cognitive impairment can be approached 6. End-stage liver failure with jaundice 7. End-stage heart failure with breathlessness at rest prior to injury 8. Those unable to communicate in the English language where all reasonable attempts to source translation services are exhausted within the ED 9. Patients transferred from non-recruiting units to a recruiting site who have a lidocaine patch applied as part of standard care prior to arrival in the recruiting site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility Outcomes 1. Number of eligible patients approached is measured using study-specific screening log records throughout the trial recruitment period. 2. Proportion of approached patients that are randomised is measured using study-specific screening log, and randomisation, records throughout the trial recruitment period. 3. Attrition of participants (including both failure to complete the trial protocol and loss to follow up) is measured using research data and withdrawal records collected throughout the trial (i.e. until end of data collection). 4. Proportion of recruited patients for which the primary outcome is available and completeness of each secondary outcome measure is measured using research data collected throughout the trial (i.e. until end of data collection). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 30-day pulmonary complications are measured using patient records up to 30-day follow up. 2. Incidence of frailty syndromes / analgesia side-effects are measured using patient records to include, immobility, delirium, and constipation evaluated during the 72-hour intervention period and functional decline at discharge. Measures include the Rockwood Clinical Frailty Scale, Timed Up and Go Test, The 4-AT and Bristol Stool Chart. Development of acute delirium during inpatient stay also at 30-days (single item question). 3. All-cause mortality is measured using patient records up to 30-day follow up. 4. Intensive Care admission and length of stay are measured using patient records up to 30-day follow up. 5. Hospital re-admission within 30-days is measured using patient records up to 30-day follow up. 6. Total length of hospital stay is measured using patient records up to 30-day follow up. 7. Total opioid consumption in first 72-hours of admission is recorded from the prescribed medication administered as recorded on the patient's ambulance care record, Emergency Department drug chart or inpatient drug chart during the first 72 hours of attendance. 8. Total pain experienced over the 72-hours period are measured using the Visual Analogue Scale (VAS), and the Abbey pain scale over the 72-hour intervention period. 9. Health economic scoping is measured by the EQ-5D-5L questionnaire at baseline (retrospective pre-injury and post injury) and 30-days. The ICECAP-O and Chest Trauma Score (RibPROM) questionnaires at 30-days. Plus, information on key costs such as length of stay, intensive care use and medication prescribing will be recorded from patient records up to 30-day follow up. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactMadeleine Clout
Outcome results
None listed