Background
I spend some of my time as a major trauma consultant on the major trauma ward (MTW). You may be shocked to hear that an Emergency Medicine doctor such as myself would ever relish a ward round….., but it’s really interesting and a fascinating way to learn more about trauma and the ongoing management of trauma patients beyond the ED. It’s made me a better clinician, and it has also improved my understanding of other specialities and those of us. That’s no bad thing; better understanding undoubtedly leads to better working practices.
A major part of the work is the management of chest wall injuries. These are really important for patients as they can lead to significant morbidity, especially pain, which can then hamper all other aspects of their recovery. Rib fractures are a particularly common concern in the elderly population due to the associated risks of pain and pulmonary complications. In older adults, these injuries can severely compromise respiratory function, leading to pneumonia and other life-threatening conditions.
In our setting, we have a fairly well-established approach to chest injury, which involves the use of opioid analgesics to manage pain, but these medications come with substantial risks, including respiratory depression, sedation, and delirium, particularly in older patients. We also use PCAs and blocks (mostly ESP, but increasingly early SA as well), and we are recruiting to the ORIF rib fixation study. Despite this, we still find difficulties in some patients.
One option is to use lidocaine patches, which have emerged as a potential non-invasive alternative to manage pain without the adverse effects associated with opioids. Despite promising results in smaller studies, their efficacy and feasibility in an emergency setting for older adults remain under-explored. In this post, we look at a feasibility study which sought to determine whether a larger trial investigating the use of lidocaine patches in elderly patients with rib fractures is feasible, focusing on aspects such as recruitment, retention, and data collection. The abstract is below, but as always, please read the full paper yourself.
The Abstract
Background: Lidocaine patches, applied over rib fractures, may reduce pulmonary complications in older patients. Known barriers to recruiting older patients in emergency settings necessitate a feasibility trial. We aimed to establish whether a definitive randomised controlled trial (RCT) evaluating lidocaine patches in older patients with rib fracture(s) was feasible.
Methods: This was a multicentre, parallel-group, open-label, feasibility RCT in seven hospitals in England and Scotland. Patients aged ≥65 years, presenting to ED with traumatic rib fracture(s) requiring hospital admission were randomised to receive up to 3×700 mg lidocaine patches (Ralvo), first applied in ED and then once daily for 72 hours in addition to standard care, or standard care alone. Feasibility outcomes were recruitment, retention and adherence. Clinical end points (pulmonary complications, pain and frailty-specific outcomes) and patient questionnaires were collected to determine feasibility of data collection and inform health economic scoping. Interviews and focus groups with trial participants and clinicians/research staff explored the understanding and acceptability of trial processes.
Results: Between October 23, 2021 and October 7, 2022, 206 patients were eligible, of whom 100 (median age 83 years; IQR 74-88) were randomised; 48 to lidocaine patches and 52 to standard care. Pulmonary complications at 30 days were determined in 86% of participants and 83% of expected 30-day questionnaires were returned. Pulmonary complications occurred in 48% of the lidocaine group and 59% in standard care. Pain and some frailty-specific outcomes were not feasible to collect. Staff reported challenges in patient compliance, unfamiliarity with research measures and overwhelming the patients with research procedures.
Conclusion: Recruitment of older patients with rib fracture(s) in an emergency setting for the evaluation of lidocaine patches is feasible. Refinement of data collection, with a focus on the collection of pain, frailty-specific outcomes and intervention delivery are needed before progression to a definitive trial.
Trial registration number: ISRCTN14813929.
Clout M, Turner N, Clement C, Braude P, Benger J, Gagg J, Gendall E, Holloway S, Ingram J, Kandiyali R, Lewis A, Maskell NA, Shipway D, Smith JE, Taylor J, Darweish Medniuk A, Carlton E. The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures. Emerg Med J. 2024 May 16:emermed-2024-213905. doi: 10.1136/emermed-2024-213905. Epub ahead of print. PMID: 38760021.
What Kind of Study is This
This research is a multicentre, randomised, controlled feasibility trial designed to test the practical aspects of conducting a larger definitive trial. Conducted over 12 months from October 2021 to October 2022, the study involved seven sites and aimed to assess the feasibility of recruiting, randomising, and retaining older patients with rib fractures in an emergency setting. The trial also sought to evaluate adherence to the intervention (lidocaine patches) and the feasibility of collecting various clinical and patient-reported outcomes.
The key point here is that the point of the trial was to test the feasibility of a future trial. It was not to determine whether one treatment is better than the other. It’s not designed for that, it’s not powered for that and as a result we should be cautious about interpreting the clinical findings.
Tell Me About the Patients
The study included adults aged 65 and older who had sustained rib fractures and required hospital admission. The majority of participants were women (47%) of white British ethnicity (92%), with a median age of 83 years. Most were admitted from their homes and were independent before their injury, although they exhibited mild frailty, with a median Clinical Frailty Scale of 4. The most common cause of injury was a fall from standing height, and participants had an average of four rib fractures. This demographic reflects a typical profile of elderly patients with rib fractures, highlighting the importance of effective and safe pain management strategies for this vulnerable group.
Tell me about the outcome measures.
The study’s primary focus was on feasibility outcomes, including recruitment rates, retention rates, adherence to the intervention, and data completeness.
In addition, the researchers collected various clinical measures to assess the feasibility of including these in a larger trial. These should still be considered secondary outcomes and included:
- Pain scores, measured using the Visual Analogue Scale (VAS) and the Abbey Pain Scale
- Incidence of pulmonary complications at 30 days
- Delirium incidence
- Length of hospital stay
- Resource use, including intensive care unit length of stay, unplanned readmissions, and discharge destinations
Patient-reported outcomes were measured using the EQ-5D-5L and ICECAP-O questionnaires, completed at baseline and 30 days post-randomisation. These measures were crucial in evaluating the overall health status and quality of life of the participants before and after the intervention.
What Are the Main Results
Between October 2021 and October 2022, 447 patients were assessed for eligibility, of which 206 met the inclusion criteria. Out of these, 100 patients were randomised, with 48 allocated to receive lidocaine patches and 52 to standard care. The median age of the participants was 83 years, and the majority had sustained their injuries from falls.
Recruitment and retention were pretty good, with 86% of participants completing the primary outcome data collection at 30 days. Adherence to the intervention was high, with 79% of participants in the lidocaine patch group receiving at least one patch. However, there was significant crossover in the standard care group, with 33% of participants receiving a lidocaine patch despite not being allocated to that arm. That crossover is important to note as it’s likely to happen in any future trial too.
Although the clinical outcomes were not the trial’s primary aim, it revealed that 53% of participants experienced pulmonary complications within 30 days. The median length of hospital stay was 9.1 days, and over 30% of participants did not return to their baseline functional status on discharge. Pain and frailty-specific outcomes were challenging to collect, with data completeness for these measures being less than 65%. That suggests that this is indeed a sick group of patients with potential opportunities for improvement.
Patient-reported outcomes showed partial recovery in health status at 30 days post-injury, with the EQ-5D-5L and ICECAP-O measures indicating that participants had not fully returned to their pre-injury health levels.
What about the methods?
This is a well-designed feasibility study and has several strengths. Recruitment across multiple sites is a positive as was the involvement of patients and the public throughout. There were problems found, such as the high crossover rate in the control group and data collection challenges for pain and frailty-specific outcomes. However, in a feasibility trial, these should not really be considered failures. Part of the reason for doing a feasibility trial is to explore such difficulties to mitigate or account for them in any future design.
Similarly. the small sample size limits the ability to draw definitive conclusions about the clinical effectiveness of lidocaine patches.
Potential biases include selection bias due to the requirement for radiological confirmation of rib fractures, possibly excluding less severely injured patients. Additionally, response bias in patient-reported outcomes was noted, particularly due to the unblinded nature of the intervention.
Should We Change Practice Based on This Study
I would not. It’s just not that sort of trial, and we would need better evidence to come to a firm conclusion. I will still use patches occasionally when other options are not working, but it really is anecdotal evidence for me at the moment, and I would really welcome a more definitive evidence base to guide my practice and our pathways. My hope is that any future trial will address these methodological issues found here, and possibly include a placebo-controlled design to better assess the effectiveness of lidocaine patches.
Summary
This feasibility trial has provided insights into the practicalities of conducting a larger, definitive trial on the use of lidocaine patches for pain management in elderly patients with rib fractures. The results of this trial and other literature suggest some promise, and I hope that we eventually get a larger, well-designed, placebo-controlled trial to conclusively determine the potential benefits/harms.
References
- Clout M, Turner N, Clement C, Braude P, Benger J, Gagg J, et al. The RELIEF feasibility trial: topical lidocaine patches in older adults with rib fractures. Emerg Med J. 2024;0:1-10.
- Barrett-Connor E, Nielson CM, Orwoll E, et al. Epidemiology of rib fractures in older men: osteoporotic fractures in men (MrOS) prospective cohort study. BMJ. 2010;340:c1069.
- Battle C, Carter K, Newey L, et al. Risk factors that predict mortality in patients with blunt chest wall trauma: an updated systematic review and meta-analysis. Emerg Med J. 2023;40:369-78.
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- Ingalls NK, Horton ZA, Bettendorf M, et al. Randomized, double-blind, placebo-controlled trial using lidocaine patch 5% in traumatic rib fractures. J Am Coll Surg. 2010;210:205-9.
- Johnson M, Strait L, Ata A, et al. Do lidocaine patches reduce opioid use in acute rib fractures? Am Surg. 2020;86:1153-8.
- Battle C, Hutchings H, Lovett S, et al. Predicting outcomes after blunt chest wall trauma: development and external validation of a new prognostic model. Crit Care. 2014;18:R98.
- Hackert MQN, van Exel J, Brouwer WBF. Does the ICECAP-O cover the physical, mental and social functioning of older people in the UK? Qual Life Res. 2019;28:761-70.