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 4

Recruiting

• Conditions: Distal Radius Fractures; Fracture Dislocation; Fracture Dislocation of Upper Limb Joint; Colles' Fracture; Closed Reduction of Fracture and Application of Plaster Cast

• Registration Number: NCT06678438
• Lead Sponsor: Nordsjaellands Hospital

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

2. A haematoma block, which is the current standard anaesthesia in the emergency departments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-06
• Study First Submitted QC: 2024-11-06
• Study First Posted: 2024-11-07
• Study Start: 2024-12-10
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-17
• Primary Completion: 2026-11
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1716

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cumulative proportion of patients with distal radius fracture surgery	90 days after closed reduction

Secondary Outcome Measures

Name	Time	Method
Composite outcome of treatment related complications	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
Patient Rated Wrist Evaluation (PRWE)	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
Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction	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.
Maximum pain score in the affected wrist during closed reduction(s)	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.

Trial Locations

Locations (1)

Copenhagen University Hospital - North Zealand Hillerød; 🇩🇰 Hillerød, Capital Region, Denmark