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
1,716 participants
Dec 10, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Exclusion Criteria9
- 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.
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Interventions
The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06678438