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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNordsjaellands Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided brachial plexus block

    Procedure/Surgery

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

  • Haematoma Block

    Procedure/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

Treatment groups

1,716 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

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

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

Time frame
90 days after closed reduction
2

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

Time frame
90 days after closed reduction
3

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.

Time frame
0-12 hours after the closed reduction
4

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.

Time frame
0 -24 hours after closed reduction

Other outcomes

1

Pain at rest in the affected wrist immediately, 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.

Time frame
0-12 hours, 90 days and 12 months after closed reduction
2

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

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

Time frame
24-36 hours after the closed reduction.
3

Proportion of patients with complex regional pain syndrome (CRPS)

CRPS is defined according to the Budapest Criteria

Time frame
90 days and 12 months after closed reduction
4

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

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

Time frame
90 days and 12 months after closed reduction

Sponsors and contacts

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