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.

Study Overview

• Status: Recruiting
• Conditions: Colles' Fracture; Fracture Dislocation; Distal Radius Fractures; Closed Reduction of Fracture and Application of Plaster Cast; Fracture Dislocation of Upper Limb Joint
• Intervention / Treatment: Procedure: Ultrasound-guided brachial plexus block; Procedure: Haematoma Block

• Study Type: Interventional
• Enrollment (Estimated): 1716
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cecilie D Harwood, MD, PhD-fellow; Phone Number: +45 48 29 20 12; Email: cecilie.dupont.harwood.01@regionh.dk
• Study Contact Backup: Name: Anders K Nørskov, MD, PhD; Phone Number: +45 48 29 74 59; Email: anders.kehlet.noerskov@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Hillerød, Capital Region, Denmark, 3400
      • Recruiting
      • Copenhagen University Hospital - North Zealand Hillerød
      • Contact: Anders Kehlet Nørskov, MD, PhD, Associate Professor; Phone Number: +45 48292510; Email: anders.kehlet.noerskov@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Ultrasound-guided brachial plexus nerve block. A total of 30 ml of lidocaine (10 mg/ml) with adrenaline (5 ug/ml) will be administered in multiple injections.	Procedure: Ultrasound-guided brachial plexus block; The block will be performed as either a lateral infraclavicular brachial plexus block or an axillary brachial plexus block
Active Comparator: Control group; Haematoma block with local anaesthetics i.e. lidocaine with adrenaline	Procedure: Haematoma Block; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative proportion of patients with distal radius fracture surgery	90 days after closed reduction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	0 -24 hours after closed reduction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-12 hours, 90 days and 12 months after closed reduction
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.	24-36 hours after the closed reduction.
Proportion of patients with complex regional pain syndrome (CRPS)	CRPS is defined according to the Budapest Criteria	90 days and 12 months after closed reduction
Disabilities of the Arm, Shoulder, and Hand (DASH) score	DASH-score is calculated from the Danish-validated translation of the DASH questionnaire	90 days and 12 months after closed reduction
Patient Rated Wrist Evaluation (PRWE)	PRWE-score is calculated from the Danish-validated translation of the PRWE questionnaire	12 months after closed reduction
Quality of life (EQ-5D-5L) score	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	90 days and 12 months after closed reduction
Number of attempts used for closed reduction		Immediately after closed reduction
Difficulty of closed reduction of the fracture	The doctor reported ease on a numeric rating scale from 0-10; 0=very easy, 10=very difficult)	Immediately after closed reduction
Discomfort related to the anaesthetic procedure	The discomfort is a patient-reported outcome on a numeric rating scale from 0-10; 0=no discomfort, 10=very uncomfortable	0-12 hours after closed reduction
Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia	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.	24 hours after closed reduction
Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-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.	10-14 days after closed reduction
Proportion of individual complications in the composite secondary outcome		90 days after closed reduction
Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function	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.	Within 90 days after closed reduction
Proportion of patients having one or more adverse events (AEs)	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.	Within 24 hours after closed reduction

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Investigators: Principal Investigator: Cecilie D Harwood, MD, PhD-fellow, Copenhagen University Hospital - North Zealand; Principal Investigator: Anne-Sofie Jellestad, MD, PhD-fellow, Copenhagen University Hospital - North Zealand

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 7, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Lidocaine; Distal radius fracture; Peripheral nerve block; Colles' fracture; Brachial plexus block; Local anaesthesia; Regional anaesthesia; Wrist fracture; Lateral infraclavicular block; Axillary plexus block
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Joint Diseases; Hemorrhage; Arm Injuries; Forearm Injuries; Wrist Injuries; Fracture Dislocation; Wrist Fractures; Fractures, Bone; Joint Dislocations; Hematoma; Radius Fractures; Colles' Fracture; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: CTA no: 2024-512191-35-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No