NCT06678438 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 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Nordsjaellands Hospital |
| Condition | Distal Radius Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,716 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,716 participants in total. It began in 2024-12-10 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Cecilie D Harwood, MD, PhD-fellow
PRINCIPAL INVESTIGATOR
Copenhagen University Hospital - North Zealand
Frequently Asked Questions
Who can join the NCT06678438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Distal Radius Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06678438 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06678438 currently recruiting?
Yes, NCT06678438 is actively recruiting participants. Contact the research team at cecilie.dupont.harwood.01@regionh.dk for enrollment information.
Where is the NCT06678438 trial being conducted?
This trial is being conducted at Hillerød, Denmark.
Who is sponsoring the NCT06678438 clinical trial?
NCT06678438 is sponsored by Nordsjaellands Hospital. The principal investigator is Cecilie D Harwood, MD, PhD-fellow at Copenhagen University Hospital - North Zealand. The trial plans to enroll 1,716 participants.