Actively Recruiting
Led by Nordsjaellands Hospital · Updated on 2025-06-17
1716
Participants Needed
1
Research Sites
21 weeks
Total Duration
Researchers are evaluating the benefits and risks of using an ultrasound-guided brachial plexus nerve block compared to a haematoma block for adults with distal radius (wrist) fractures who need realignment of the broken bone without surgery (closed reduction). This study is a Phase 4 multicenter randomized controlled trial aiming to compare these two anesthesia methods to improve care for wrist fractures. Participants will be randomly assigned to receive either an ultrasound-guided brachial plexus nerve block or the standard haematoma block during the closed reduction procedure. The nerve block involves administering 30 ml of lidocaine with adrenaline through multiple injections near the brachial plexus, either via a lateral infraclavicular or axillary approach. The haematoma block group will receive local anesthesia with or without additional sedation or pain relief as per local practices. During the study, researchers will monitor participants for 90 days after the closed reduction to assess the need for surgery, complications related to treatment, wrist function using the Patient Rated Wrist Evaluation (PRWE), pain levels during the procedure, and the quality of the fracture alignment immediately after treatment. Participants will be closely followed with these evaluations to understand the effectiveness and safety of each anesthesia method, with the total participation lasting at least 3 months after the procedure.
CONDITIONS
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Up to 12 hours including procedure and immediate recovery
Participants receive either an ultrasound-guided brachial plexus nerve block or a haematoma block to manage pain during closed reduction of a distal radius fracture.
1 treatment visit (in-person)
Duration - 90 days after closed reduction
Participants are monitored for treatment outcomes, complications, pain levels, and fracture position after closed reduction.
Visits at various points up to 90 days post-treatment for assessments
Total: 1 location
1
Copenhagen University Hospital - North Zealand Hillerød
Hillerød, Capital Region, Denmark, 3400
Actively Recruiting
C
Cecilie D Harwood, MD, PhD-fellow
A
Anders K Nørskov, MD, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Cecilie Dupont Harwood, Anne-Sofie Linde Jellestad, Aurelien-Xuan Rosendal Bahuet...
https://pubmed.ncbi.nlm.nih.gov/40633950