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Recruiting NCT06678438

Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.

Phase IV Interventional Distal Radius Fractures Fracture Dislocation Fracture Dislocation of Upper Limb Joint Colles' Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided brachial plexus block, Haematoma Block.
Who it may be relevant to
Registry conditions: Distal Radius Fractures, Fracture Dislocation, Fracture Dislocation of Upper Limb Joint, Colles' Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The aim of the project is to evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius (wrist) fracture in the need of realignment of fractured bone endings without cutting the skin (closed reduction), in comparison to a haematoma block, which is standard care in Denmark. Every participant will receive one of the following types of anaesthesia for the realignment of the wrist fracture: 1. A nerve block of the arm (plexus brachialis block) 2. A haematoma block, which is the current standard anaesthesia in the emergency departments.

Interventions

  • Procedure Ultrasound-guided brachial plexus block
    The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block
  • Procedure Haematoma Block
    Participants will receive no peripheral nerve block and receive a haematoma block, with or without supplemental sedation and/or systemic analgesia for the closed reduction according to local guidelines and clinical practices

Primary outcome measures

  • Cumulative proportion of patients with distal radius fracture surgery [Time frame: 90 days after closed reduction]
Secondary outcome measures (4)
  • Composite outcome of treatment related complications [Time frame: 90 days after closed reduction]
  • Patient Rated Wrist Evaluation (PRWE) [Time frame: 90 days after closed reduction]
  • Maximum pain score in the affected wrist during closed reduction(s) [Time frame: 0-12 hours after the closed reduction]
  • Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction [Time frame: 0 -24 hours after closed reduction]

Eligibility criteria

Inclusion criteria

  • Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction

Exclusion criteria

  • Patients who would never qualify for surgery according to local guidelines
  • Lack of informed consent
  • No Danish Central Person Register (CPR) number
  • Allergies to the trial medication
  • Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
  • Open fractures (fracture-related wound requiring sutures)
  • Other fractures on the same extremity ((NOT including distal ulna fracture(s))
  • Bilateral distal radius fractures both requiring closed reduction
  • Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Copenhagen University Hospital - North Zealand Hillerød — Hillerød

Publications

  • Dupont Harwood C, Jellestad AL, Bahuet AR, Knudsen RL, Andersen LC, Mathiesen O, Asko Andersen J, Jakobsen JC, Rothe C, Jorgensen CC, Viberg B, Brorson S, Brabrand M, Gundtoft PH, Terndrup M, Lange KHW, Lundstrom LH, Norskov AK. Brachial plexus nerve block versus haematoma block for closed reduction of distal radius fracture in adults: The BLOCK Trial - a protocol for a multicentre randomised cont PMID 40633950

Identifiers

NCT: NCT06678438 · CTA no: 2024-512191-35-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗