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

Phase 4RecruitingNCT06678438

Nordsjaellands Hospital1,716 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,716

Conditions

Distal Radius Fractures Fracture Dislocation Fracture Dislocation of Upper Limb Joint Colles' Fracture

Interventions

Ultrasound-guided brachial plexus blockPROCEDURE

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

Haematoma BlockPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Cumulative proportion of patients with distal radius fracture surgery

Time frame: 90 days after closed reduction

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 0 -24 hours after closed reduction

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts