About
The BLOCK Trial is a national, multicentre, randomised, controlled, clinical trial comparing a brachial plexus block versus standard care for closed reduction of distal radius fractures in non-frail patients.
Introduction
Distal radius fracture (DRF) accounts for one-fifth of all fractures in the active elderly population. In Denmark alone, more than 14,000 adult patients are diagnosed with DRF annually and numbers are increasing. The majority of patients with DRFs are treated with non-surgical realignment (closed reduction) followed by immobilisation in a cast.
However, approximately 30% subsequently undergo surgery because of unacceptable fracture realignment after closed reduction.
A haematoma block, defined as a local anaesthetic injected into the fracture site, is a commonly used standard care analgesic for closed reduction but is suboptimal for pain management during closed reduction. A brachial plexus nerve block, such as the lateral infraclavicular (LIC) brachial plexus block or the axillary (AXIL) brachial plexus block, induces both muscular relaxation and blocks pain transmission from the distal two-thirds of the arm. It may therefore be possible to perform the closed reduction without pain or muscular resistance.
Patients
The trial will include 1,700 adult, non-frail patients with a DRF in need of closed reduction at the emergency department.
Intervention & Control
Intervention group
Ultrasound-guided LIC or AXIL block administered with 30 ml of lidocaine (10 mg/ml) with adrenaline (5ug/ml), performed by an anaesthetist skilled in the procedure.
Control group
Will receive standard care as defined by the centre. It is predominately expected to involve a haematoma block with local anaesthetic.
Both groups will receive conventional post-reduction pain medication according to departmental standards.
Outcomes
The primary outcome is the cumulative proportion of patients with DRF surgery at day 90 after closed reduction
Secondary outcomes will assess patient-reported wrist function after 3 months, pain levels during the reduction procedure and the post-reduction radiographic position.
For a more detailed description of The BLOCK Trial please read our trial synopsis.
Timeline and outcomes of patients randomised to either standard care (haematoma block) or brachial plexus block during closed reduction, from trauma to end of follow-up.
ED: Emergency Department. DRF: Distal Radius Fracture. NRS: Numerical Rating Scale. SAE: Serious Adverse Events. DASH: Disabilities of the Arm, Shoulder, and Hand. PRWE: Patient Rated Wrist Evaluation. EQ-5D-5L: Quality of life score. CRPS: Complex Regional Pain Syndrome. ICER: Incremental Cost-Effectiveness Ratio.