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

NCT06678438 | Recruiting Phase 4 DMC

• 1 other identifier: CTA no: 2024-512191-35-00
• Study Type: interventional
• Target: 1,716
• Locations: 1 country
• Sites: 1

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. 1.A nerve block of the arm (plexus brachialis block)
2. 2.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

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

Outcome Measures

Primary Outcomes (1)

• Cumulative proportion of patients with distal radius fracture surgery

  90 days after closed reduction

Secondary Outcomes (4)

• Composite outcome of treatment related complications

  90 days after closed reduction

• Patient Rated Wrist Evaluation (PRWE)

  90 days after closed reduction

• Maximum pain score in the affected wrist during closed reduction(s)

  0-12 hours after the closed reduction

• Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction

  0 -24 hours after closed reduction

Other Outcomes (14)

• Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction

  0-12 hours, 90 days and 12 months after closed reduction

• Maximum pain in the affected wrist within the first 24 hours after closed reduction

  24-36 hours after the closed reduction.

• Proportion of patients with complex regional pain syndrome (CRPS)

  90 days and 12 months after closed reduction

Study Arms (2)

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.

Procedure: Ultrasound-guided brachial plexus block

Control group

ACTIVE COMPARATOR

Haematoma block with local anaesthetics i.e. lidocaine with adrenaline

Procedure: Haematoma Block

Interventions

Ultrasound-guided brachial plexus block PROCEDURE

The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block

Intervention group

Haematoma Block PROCEDURE

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

Copenhagen University Hospital - North Zealand Hillerød

Hillerød, Capital Region, 3400, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 40633950 DERIVED

MeSH Terms

Conditions

Wrist Fractures; Fracture Dislocation; Colles' Fracture

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Radius Fractures

Study Officials

• Cecilie D Harwood, MD, PhD-fellow

  Copenhagen University Hospital - North Zealand

  PRINCIPAL INVESTIGATOR

• Anne-Sofie Jellestad, MD, PhD-fellow

  Copenhagen University Hospital - North Zealand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilie D Harwood, MD, PhD-fellow

CONTACT

48 29 20 12; cecilie.dupont.harwood.01@regionh.dk

Anders K Nørskov, MD, PhD

CONTACT

48 29 74 59; anders.kehlet.noerskov@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is unfeasible to blind the patients, the doctor who performs the brachial plexus nerve block and the doctor who performs the standard care and the closed reduction. As a result, data on patient evaluated outcomes, i.e. maximum pain score during closed reduction; maximum pain within the first 24 hours after closed reduction; pain at rest; discomfort related to the anaesthetic procedure; overall satisfaction with the treatment; PRWE; DASH; EQ-5D-5L; and data on the closed reduction, i.e. number of attempts used for closed reduction and difficulty of closed reduction of the fracture, will be reported unblinded. Importantly, other caregivers and all outcome assessors are blinded, including the doctor who evaluate the radiographic results and assess the need for surgery, as well as all personnel involved in the subsequent outcome evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 7, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 17, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)