Comparing Nerve Block and Haematoma Block for Wrist Fracture Realignment in Adults
A Multicenter Randomized Study on Distal Radius Fracture Treatment
Led by Nordsjaellands Hospital · Updated on 2025-06-17
1716
Participants Needed
1
Research Sites
21 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Research Team
C
Cecilie D Harwood, MD, PhD-fellow
A
Anders K Nørskov, MD, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Patients not qualifying 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 requiring surgery regardless of closed reduction outcome
Open fractures requiring wound sutures
Other fractures on the same arm except distal ulna fractures
Bilateral distal radius fractures both needing closed reduction
Medical or surgical conditions that take priority over wrist fracture treatment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Treatment
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)
Follow-up
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Comparing Nerve Block and Haematoma Block for Wrist Fracture Realignment in Adults
A Multicenter Randomized Study on Distal Radius Fracture Treatment
Study of Fus Subcutaneous Needling with Rehabilitation to Help Healing of Distal Radius Fractures in Adults Aged 18 to 85
Study Comparing Cannulated Screw and K-wire Fixation for Distal Radius Fractures in Adults Aged 18 to 60
Study of Ru-Yi-Jin-Huang-Saan Patch for Treating Colles Fracture After Surgery
Randomized, Double-blind, Placebo-Controlled Phase 2 Trial
Long-Term Safety and Performance Study of Equinoxe Proximal Humerus Fracture Plates
A Multi-Center Observational Follow-Up Over 10 Years Post-Surgery
Effect of Early Daily Activity Education on Recovery After Distal Radius Fracture Surgery with Open Reduction and Internal Fixation
Comparison of Compression Bandage and Forearm Splint Immobilization for Distal Radius Fractures Treated with Volar Locking Plate Surgery
Long-Term Safety Study of NVDX3, a Human Bone Implant,
Following Previous Treatment for Bone Conditions
Study Comparing Mechanical Devices Plus Standard Therapy Versus Standard Therapy Alone for Managing Swelling and Pain After Wrist Bone Surgery
Comparing Opioid and Opioid-Free Pain Relief After Orthopedic Trauma Surgery
A Randomized Study at University of Kansas Medical Center
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
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.