Spinal medial branch nerve root block (MBNB) intervention compared to standard care-vertebroplasty (VP) for the treatment of painful osteoporotic vertebral fractures in frail, older hospitalised patients: a feasibility study.

Our study aimed to assess the feasibility outcomes comparing spinal medial branch nerve root block intervention to standard care vertebroplasty for the treatment of painful osteoporotic vertebral fractures in frail, hospitalised older patients. We found the study to be feasible and now propose a clinical effectiveness, cost effectiveness and safety evaluation. INTRODUCTION: Vertebroplasty (VP) is a key-hole procedure involving injection of bone cement into a fractured vertebral body, to reduce pain and increase vertebral body stability, although it is associated with a small risk of complications, particularly in frail, older hospitalised patients. Medial branch spinal nerve block (MBNB) may be an alternative treatment to alleviate pain symptoms, with less complications; however, no study has prospectively compared the clinical effectiveness, cost-effectiveness and safety of MBNB to VP, in frail, older hospitalised patients. The aim of our study was to conduct a 1st stage feasibility study, exploring recruitment, retention and several outcomes measures (means and SDs), together with qualitative interviews to assess participant and clinician views, to inform a definitive larger study. METHODS: We conducted a two-arm feasibility randomised controlled trial with participants allocated to continue with routine surgical care-VP or MBNB treatment, with an embedded qualitative study. Data was collected at baseline, week 1, 4, and week 8. RESULTS: Out of 40 eligible patients, 30 (75%) consented to take part in the study. The overall median time from randomisation to intervention was 3 days, IQR 1-7 days, 5 (1-7) days for VP and 2 (1-3) days for MBNB. Median (IQR) length of hospital stay for the VP group was 20 (8) days and for the MBNB 15(22) days. The proportion of completeness of outcome data collection at weeks 1, 4 and 8 was at least 77%: 14 (100%), 12 (85.7%) and 11(78.9%) for VP and 13 (100%), 12 (92.3%) and 10 (76.8%) for MBNB, respectively. There were no significant difference in the clinical outcomes or adverse events between the two groups. DISCUSSION: Our study was feasible in achieving is target recruitment, participants adhered to the randomisation and at least 77% completeness of data at the 8 week end-point (target 75%). We now plan to conduct a definitive clinical effectiveness, cost effectiveness and safety outcome study, comparing VP to MBNB in frail, older patients hospitalised with an acute vertebral osteoporotic fracture.

The Acute VertEbRal AugmentaTion (AVERT) study: protocol for a randomised controlled, feasibility trial of spinal medial branch nerve block in hospitalised older patients with vertebral fragility fractures.

INTRODUCTION: Vertebral fragility fractures (VFFs) are the most common type of osteoporotic fracture found in older people, resulting in increasing morbidity and excess mortality. These fractures can cause significant pain, requiring admission to hospital. Vertebroplasty (VP) is effective in reducing pain and allowing early mobilisation in hospitalised patients. However, it may be associated with complications such as cement leakage, infection, bleeding at the injection site and fracture of adjacent vertebrae. It is also costly and not readily accessible in many UK hospitals.A recent retrospective study reported that spinal medial branch nerve block (MBNB), typically used to treat facet arthropathy, had similar efficacy in terms of pain relief compared with VP for the treatment of painful VFF. However, to date, no study has prospectively compared MBNB to VP. We therefore propose a prospective feasibility randomised controlled trial (RCT) to compare the role of MBNB to VP, in hospitalised older patients. METHOD: A parallel, two-arm RCT with participants allocated on a 1:1 ratio to either standard care-VP or MBNB in hospitalised patients aged over 70 with acute osteoporotic vertebral fractures. Follow-up will be at weeks 1, 4 and 8 post intervention. The primary objective is to determine the feasibility and design of a future trial, including specific outcomes of recruitment, adherence to randomisation and safety. Embedded within the trial will be a health economic evaluation to understand resource utilisation and implications of the intervention and a qualitative study of the experiences and insights of trial participants and clinicians. Secondary outcomes will include pain scores, analgesia requirements, resource use and quality of life data. ETHICS AND DISSEMINATION: Ethical approval was granted by the Yorkshire & the Humber Research Ethics Committee (reference 21/YH/0065). AVERT (Acute VertEbRal AugmentaTion) has received approval by the Health Research Authority (reference IRAS 293210) and is sponsored by Nottingham University Hospitals NHS Trust (reference 21HC001). Recruitment is ongoing. Results will be presented at relevant conferences and submitted to appropriate journals for publication on completion. TRIAL REGISTRATION NUMBER: ISRCTN18334053.

Perioperative Pain Management in the Critically Ill Patient.

PURPOSE OF REVIEW: The assessment and management of perioperative pain in an intensive care setting is complex and challenging, requiring several patient-specific considerations. Administering analgesia is difficult due to interacting effects of pre-existing conditions, interventions, and deviation from standard levels of expressiveness of pain. A significant part of this complexity also arises from the reduced capacity of critically ill patients to fully communicate the severity and nature of their pain. We provide an overview of pharmacological approaches and regional techniques, which can be employed alongside the management of anxiety and sleep, to alleviate pain in the critically ill patients in the perioperative period. These interventions require additional assessments unique to critical care, yet achieving pain relief for improving clinical outcomes and patient satisfaction remains a constant. RECENT FINDINGS: The latest research has found that the development of standardized mechanisms and protocols to optimize the diagnosis, assessment, and management of pain in the critically ill can provide the best outcomes. The numerical rating scale, critical care pain observation criteria, and behavior pain scale has shown higher reliability to accurately assess pain in the critically ill. Most importantly, preemptive analgesia and the emphasis on early pain control-in the perioperative setting, ICU, and post-discharge-are crucial in minimizing chronic post-discharge pain. Finally, the multimodal approach is still found to be the most effective. This includes pharmacological treatments, regional nerve block, and epidural techniques, as well as alternative methods that are cheap, safe, and easily available. All these together have shown to help control pain, provide psychological support, and prevent long-term co-morbidities in the critically ill. Largely, pain in the critically ill patient is still a very complex issue that requires appropriate diagnosis, assessment, and management of the pain itself and treating all the underlying co-morbidities as well. Many different factors makes it challenging, especially the difficulty in communicating with an ICU patient. However, by looking at the patient as a whole, treating pain early with the multimodal approach, there seems to be some promising results in improving outcomes. It has shown that the improved outcomes in critically ill patients in the perioperative period seen with optimized pain management and ICU can shorten hospital stays, decreased inpatient costs, and limit the use of limited resources.