Pain control in older patients with rib fractures: A randomised feasibility trial of lidocaine patches

Not Applicable

Completed

• Conditions: Elderly patients admitted to hospital with rib fractures; Injury, Occupational Diseases, Poisoning; Fracture of rib(s), sternum and thoracic spine

• Registration Number: ISRCTN14813929
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

2023 Protocol article in https://doi.org/10.3310/nihropenres.13438.1 v1 (added 01/08/2023) 2023 Protocol article in https://doi.org/10.3310/nihropenres.13438.2 v2 (added 26/10/2023) 2024 Results article in https://doi.org/10.1136/emermed-2024-213905 (added 20/05/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-22
• Study Completion: 2023-03-31
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility Outcomes<br>1. Number of eligible patients approached is measured using study-specific screening log records throughout the trial recruitment period.<br>2. Proportion of approached patients that are randomised is measured using study-specific screening log, and randomisation, records throughout the trial recruitment period.<br>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).<br>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).