Distal radius fractures account for one-fifth of all fractures in the active elderly population and may cause chronic pain, loss of hand function and reduced work productivity, imposing a significant socioeconomic burden. Most are initially treated with closed reduction and casting, but 30% subsequently require surgery due to insufficient realignment. The current approaches for analgesia for closed reduction are suboptimal. A brachial plexus nerve block provides complete pain relief and muscle relaxation distal to the elbow, potentially creating better conditions for realignment of the fractured bone ends. This may ultimately translate into reduced need for surgery and result in better functional outcomes and fewer complications compared to a haematoma block, which is the current standard care in Denmark.
The BLOCK Trial is an investigator-initiated, parallel-group, allocation-concealed, outcome assessor and analyst-blinded, superiority, randomised, controlled, clinical multicentre trial performed at 11 Danish emergency departments. Eligible adult patients with a distal radius fracture who need closed reduction will be included and allocated 1:1 to either an ultrasound-guided brachial plexus nerve block or a haematoma block. The primary outcome is the proportion of patients with distal radius fracture surgery 90 days after closed reduction. We will include 1716 participants to detect or discard a relative risk reduction of surgery of 20%. Secondary outcomes include treatment-related complications, patient-reported wrist function, pain during closed reduction and proportion of patients with unacceptable radiographic fracture position immediately after closed reduction.
The trial is approved by the Danish Medicines Agency and the Danish Research Ethics Committees (EU CT number: 2024-512191-35-00). All results will be summarised on www.theblocktrial.com, clinicaltrials.gov and euclinicaltrials.eu after publication. Primary and secondary outcome results from 0 to 90 days will be presented in the main article and submitted to a peer-reviewed journal. Results from outcomes on the 12-month follow-up will be presented separately.
Patient blood management (PBM), an evidence-based, patient-centred approach for optimising blood health, faces significant implementation challenges despite regulatory support, and this study explores its adoption within a Portuguese hospital to enhance education, develop tailored protocols and address healthcare system complexities, thereby contributing a unique perspective to the global discourse on PBM in Portuguese-speaking countries. This study will evaluate the clinical outcomes and cost-effectiveness of implementing a PBM programme in elective surgical patients at a tertiary Portuguese hospital, with secondary objectives focusing on preoperative anaemia prevalence and aetiology, PBM protocol adherence, transfusion practices guided by viscoelastic tests and the impact of cell salvage techniques.
A baseline evaluation will be conducted in 2018, and postintervention assessments will follow from 2019 to 2024. The control group comprised patients who underwent selected elective surgeries—including cardiac, general, orthopaedic, urological and gynaecological procedures—during 2018 without exposure to targeted PBM interventions. The intervention group consisted of patients scheduled for the same elective surgeries, who were referred for preanaesthesia evaluation to identify the need for PBM interventions. These interventions, where indicated, were implemented during the preoperative phase and extended to the intraoperative and postoperative periods to ensure a comprehensive and standardised approach to PBM application. Data will be extracted from pseudoanonymised medical records, ensuring full compliance with ethical standards and data protection regulations. Statistical analyses will be performed using robust methods suitable for categorical and continuous variables, enabling the evaluation of temporal trends and the overall effectiveness of PBM interventions in improving clinical outcomes.
Our research has been ethically approved by the Vila Nova de Gaia/Espinho Hospital Centre’s Ethical Health Committee (approval number 196/2023–1). We plan to disseminate our findings through posters, lectures at conferences and in scientific journals.