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

Nordsjaellands Hospital

Status and phase: Enrolling; Phase 4

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

Treatments: Procedure: Ultrasound-guided brachial plexus block; Procedure: Haematoma Block

Study type: Interventional

Funder types: Other

Identifiers

NCT06678438

CTA no: 2024-512191-35-00

Details and patient eligibility

About

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.

Enrollment: 1,716 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,716 participants in 2 patient groups

Intervention group

Experimental group

Description:

Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections.

Treatment:

Procedure: Ultrasound-guided brachial plexus block

Control group

Active Comparator group

Description:

Haematoma block with local anaesthetics i.e. lidocaine with adrenaline

Treatment:

Procedure: Haematoma Block