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NCT Number: NCT06678438

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

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.

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Key information

Conditions

Distal Radius Fractures Arm Injuries Closed Reduction of Fracture and Application of Plaster Cast Colles' Fracture Fracture Dislocation Fracture Dislocation of Upper Limb Joint Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Radius Fractures Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Copenhagen University Hospital - North Zealand Hillerød

Hillerød, Capital Region, 3400, Denmark

Location status: Recruiting

Location contact

Anders Kehlet Nørskov, MD, PhD, Associate Professor

CONTACT

[email protected]

+45 48292510

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

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

Primary outcomes

  1. Cumulative proportion of patients with distal radius fracture surgery

    Time frame: 90 days after closed reduction

Secondary outcomes

  1. Composite outcome of treatment related complications

    Time frame: 90 days after closed reduction

    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

  2. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 90 days after closed reduction

    The PRWE is a patient-reported outcome and the PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire

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

    Time frame: 0-12 hours after the closed reduction

    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.

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

    Time frame: 0 -24 hours 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.

Other outcomes

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

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

    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.

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

    Time frame: 24-36 hours after the closed reduction.

    The pain outcomes are patient-reported as an NRS score on a scale from 0=no pain to 10=worst pain imaginable.

  3. Proportion of patients with complex regional pain syndrome (CRPS)

    Time frame: 90 days and 12 months after closed reduction

    CRPS is defined according to the Budapest Criteria

  4. Disabilities of the Arm, Shoulder, and Hand (DASH) score

    Time frame: 90 days and 12 months after closed reduction

    DASH-score is calculated from the Danish-validated translation of the DASH questionnaire

  5. Patient Rated Wrist Evaluation (PRWE)

    Time frame: 12 months after closed reduction

    PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire

  6. Quality of life (EQ-5D-5L) score

    Time frame: 90 days and 12 months after closed reduction

    The Danish translation of the EQ-5D-5L questionnaire is used and the EQ-5D-5L-score is calculated based on the Danish EQ-5D-5L value set

  7. Number of attempts used for closed reduction

    Time frame: Immediately after closed reduction

  8. Difficulty of closed reduction of the fracture

    Time frame: Immediately after closed reduction

    The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult)

  9. Discomfort related to the anaesthetic procedure

    Time frame: 0-12 hours after closed reduction

    The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable

  10. Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia

    Time frame: 24 hours after closed reduction

    The overall satisfaction is a patient-reported outcome on a numeric rating scale from 0-10; 0=very unsatisfied, 10=very satisfied. When evaluating the treatment, the patient is specifically asked to include all elements of the treatment including: the anaesthetic (procedure and following effects), the experience during the closed reduction and the pain and general sensation in the arm/wrist in the first 24 hours after the treatment commencement.

  11. Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction)

    Time frame: 10-14 days 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.

  12. Proportion of individual complications in the composite secondary outcome

    Time frame: 90 days after closed reduction

  13. Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function

    Time frame: Within 90 days after closed reduction

    A SAE is defined as an adverse event that leads to the following incidents:

    • Death
    • Life threatening injury or disease
    • Severe or permanent disability
    • Admission to the hospital or prolongation of hospitalisation

    Surgical reduction of the distal radius fracture, including relevant admission to hospital, will not be catagorised as a SAE.

  14. Proportion of patients having one or more adverse events (AEs)

    Time frame: Within 24 hours after closed reduction

    An AE is defined as any harmful and unintended event, sign, or symptom, that appear during the trial period, regardless of whether this AE is considered related to the treatment or not.

Study contacts

Contact information is provided by the study sponsor or research team.

Anders K Nørskov, MD, PhD

CONTACT

[email protected]

48 29 74 59 ext. +45

Cecilie D Harwood, MD, PhD-fellow

CONTACT

[email protected]

48 29 20 12 ext. +45

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 7, 2024
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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