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

NCT ID: NCT06678438

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

1716 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-10

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Due to the nature of the intervention, it is unfeasible to blind the patients, the doctor who performs the brachial plexus nerve block and the doctor who performs the standard care and the closed reduction. As a result, data on patient evaluated outcomes, i.e. maximum pain score during closed reduction; maximum pain within the first 24 hours after closed reduction; pain at rest; discomfort related to the anaesthetic procedure; overall satisfaction with the treatment; PRWE; DASH; EQ-5D-5L; and data on the closed reduction, i.e. number of attempts used for closed reduction and difficulty of closed reduction of the fracture, will be reported unblinded. Importantly, other caregivers and all outcome assessors are blinded, including the doctor who evaluate the radiographic results and assess the need for surgery, as well as all personnel involved in the subsequent outcome evaluations.

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Ultrasound-guided brachial plexus block

Intervention Type PROCEDURE

The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block

Control group

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

Group Type ACTIVE_COMPARATOR

Haematoma Block

Intervention Type PROCEDURE

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

Interventions

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Ultrasound-guided brachial plexus block

The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cecilie D Harwood, MD, PhD-fellow

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital - North Zealand

Anne-Sofie Jellestad, MD, PhD-fellow

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital - North Zealand

Locations

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Copenhagen University Hospital - North Zealand Hillerød

Hillerød, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Cecilie D Harwood, MD, PhD-fellow

Role: CONTACT

48 29 20 12 ext. +45

Anders K Nørskov, MD, PhD

Role: CONTACT

48 29 74 59 ext. +45

Facility Contacts

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Anders Kehlet Nørskov, MD, PhD, Associate Professor

Role: primary

+45 48292510

References

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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 controlled trial. BMJ Open. 2025 Jul 8;15(7):e099954. doi: 10.1136/bmjopen-2025-099954.

Reference Type DERIVED
PMID: 40633950 (View on PubMed)

Other Identifiers

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CTA no: 2024-512191-35-00

Identifier Type: -

Identifier Source: org_study_id

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