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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Enrollment closed, study ongoing Show 6 more changesShow less
    • Study completion pushed from Apr 2027 to Aug 24, 2027
    • Primary completion date: Nov 2026 to Nov 24, 2026
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Site details revised
    • Publications: details revised at 1 of 1 entry
  2. Minor Study title shortened, about 2 wordsv4
  3. Minor Eligibility criteria expanded, about 17 wordsv3
  4. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2024 to Dec 10, 2024
    • Interventions: Standard anaesthesia (Procedure), Ultrasound-guided brachial plexus block (Procedure) to Haematoma Block (Procedure), Ultrasound-guided brachial plexus block (Procedure)
    • Study title expanded, about 1 word
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06678438
Lead Sponsor Nordsjaellands Hospital
Conditions
(from sponsor)
Distal Radius Fractures, Fracture Dislocation, Fracture Dislocation of Upper Limb Joint, Colles' Fracture, Closed Reduction of Fracture and Application of Plaster Cast
Related terms Colles' Fracture, Fracture Dislocation, Wrist Fractures
Enrollment 1,716 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov