Distal Radius FracturesPhase 4NCT06678438
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
A Phase 4 study testing Ultrasound-guided brachial plexus block and Haematoma Block in people with Distal Radius Fractures and Fracture Dislocation, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures, Fracture Dislocation, Fracture Dislocation of Upper Limb Joint
- What is being tested?
- Ultrasound-guided brachial plexus block and Haematoma Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,716 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Dec 2024to 24 Aug 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital - North Zealand Hillerød
Hillerød, Capital Region, 3400
About this study
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:
- A nerve block of the arm (plexus brachialis block)
- A haematoma block, which is the current standard anaesthesia in the emergency departments.
- Conditions
- Distal Radius Fractures, Fracture Dislocation, Fracture Dislocation of Upper Limb Joint, Colles' Fracture, Closed Reduction of Fracture and Application of Plaster Cast
- Being tested
- Ultrasound-guided brachial plexus block, Haematoma Block
- Keywords
- Lidocaine, Local anaesthesia, Regional anaesthesia, Peripheral nerve block, Brachial plexus block, Lateral infraclavicular block, Axillary plexus block, Distal radius fracture, Colles' fracture, Wrist fracture
- Medical subject headings
- Wrist Fractures, Fracture Dislocation, Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided brachial plexus blockProcedure or surgery
The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block
Haematoma BlockProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections. Receives: Procedure: Ultrasound-guided brachial plexus block |
| Control group | Active comparator | Haematoma block with local anaesthetics i.e. lidocaine with adrenaline Receives: Procedure: Haematoma Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative proportion of patients with distal radius fracture surgery
Measured: 90 days after closed reduction
Secondary outcomes (4)
Composite outcome of treatment related complications
loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries (including skin injuries) related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment (including compression), pneumothorax, allergic reaction, new bone or joint injury (e.g. dislocation or fracture) after the closed reduction and/or pulmonary embolism
Measured: 90 days after closed reduction
Patient Rated Wrist Evaluation (PRWE)
The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire
Measured: 90 days after closed reduction
Maximum pain score in the affected wrist during closed reduction(s)
The pain outcomes are patient-reported as a Numerical Rating Scale (NRS) score on a scale from 0=no pain to 10=worst pain imaginable. If the patient has the closed reduction performed more than one time, the patient will be asked to report the worst pain experienced during all the attempts of a closed reduction.
Measured: 0-12 hours after the closed reduction
Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction
The radiographic fracture position is evaluated according to the American Academy of Orthopaedic Surgerons (AAOS) guidelines. The fracture position is unacceptable if the fracture has a radial shortening > 3 mm, > 10 degrees dorsal tilt of the articular surface of radius from a perpendicular line on the longitudianal axis of radius or intra-articular displacement or step-off > 2 mm.
Measured: 0 -24 hours after closed reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start10 Dec 2024
- Primary completion24 Nov 2026 (estimated)
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilie D Harwood, MD, PhD-fellow, Principal investigator, Copenhagen University Hospital - North ZealandAnne-Sofie Jellestad, MD, PhD-fellow, Principal investigator, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678438
- Sponsor's protocol ID
- CTA no: 2024-512191-35-00
- Status last verified
- Sep 2026
- First submitted
- 6 Nov 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupont Harwood C, Jellestad AL, Bahuet AR, Knudsen RL, Andersen LC, Mathiesen O, Asko Andersen J, Jakobsen JC, Rothe C, Jorgensen CC, Viberg B, Brorson S, Brabrand M, Gundtoft PH, Terndrup M, Lange KHW, Lundstrom LH, Norskov AK. 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. BMJ Open. 2025 Jul 8;15(7):e099954. doi: 10.1136/bmjopen-2025-099954.
PubMed 40633950