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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ultrasound-guided brachial plexus block
Procedure/SurgeryThe block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block
Haematoma Block
Procedure/SurgeryParticipants 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
Trial outcomes
Primary outcomes
Cumulative proportion of patients with distal radius fracture surgery
Secondary outcomes
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
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
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.
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.
Other outcomes
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.
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.
Proportion of patients with complex regional pain syndrome (CRPS)
CRPS is defined according to the Budapest Criteria
Disabilities of the Arm, Shoulder, and Hand (DASH) score
DASH-score is calculated from the Danish-validated translation of the DASH questionnaire
Sponsors and contacts
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