About

The BLOCK Trial is a national, multicentre, randomised, controlled, clinical trial comparing a brachial plexus block versus standard haematoma block for closed reduction of distal radius fractures in adults.

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 includes 1,716 adults ( ≥ 18 years) 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 a standard haematoma block with local anaesthetic according to local guidelines.

Both groups will receive conventional post-reduction pain medication according to departmental standards.

Participating emergency departments

  • Copenhagen University Hospital North Zealand Hillerød

  • Copenhagen University Hospital Bispebjerg

  • Copenhagen University Hospital, Hvidovre

  • Holbæk Sygehus

  • Slagelse Sygehus

  • Zealand University Hospital Køge

  • Odense University Hospital

  • Sygehus Lillebælt, Vejle

  • Aarhus University Hospital

  • The Regional Hospital Gødstrup.

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 fracture position.

For a more detailed description of The BLOCK Trial please read our trial synopsis or our trial protocol.

Timeline and outcomes of patients randomised to either standard 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.