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

NCT06678438 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1716

Last updated 2025-06-17

No results posted yet for this study

Summary

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.

Conditions

  • Distal Radius Fractures
  • Fracture Dislocation
  • Fracture Dislocation of Upper Limb Joint
  • Colles' Fracture
  • Closed Reduction of Fracture and Application of Plaster Cast

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

Sponsors & Collaborators

  • Nordsjaellands Hospital

    lead OTHER

Principal Investigators

  • Cecilie D Harwood, MD, PhD-fellow · Copenhagen University Hospital - North Zealand

  • Anne-Sofie Jellestad, MD, PhD-fellow · Copenhagen University Hospital - North Zealand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2026-11-30
Completion
2027-04-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06678438 on ClinicalTrials.gov