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
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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RECRUITING
PHASE4
1716 participants
INTERVENTIONAL
2024-12-10
2027-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Ultrasound-guided brachial plexus block
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
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
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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Nordsjaellands Hospital
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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CTA no: 2024-512191-35-00
Identifier Type: -
Identifier Source: org_study_id
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