Clinical trial NCT06678438: Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Official title: Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Distal Radius Fractures
Fracture Dislocation
Fracture Dislocation of Upper Limb Joint
Colles' Fracture
Closed Reduction of Fracture and Application of Plaster Cast
Keywords: Lidocaine
Local anaesthesia
Regional anaesthesia
Peripheral nerve block
Brachial plexus block
Lateral infraclavicular block
Axillary plexus block
Distal radius fracture
Colles' fracture
Wrist fracture
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 1716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative proportion of patients with distal radius fracture surgery
timeFrame: 90 days after closed reduction
Secondary outcomes:
measure: Composite outcome of treatment related complications
timeFrame: 90 days after closed reduction
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 90 days after closed reduction
measure: Maximum pain score in the affected wrist during closed reduction(s)
timeFrame: 0-12 hours after the closed reduction
measure: Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction
timeFrame: 0 -24 hours after closed reduction
Other outcomes:
measure: Pain at rest in the affected wrist immediately, 90 days, and 12 months after closed reduction
timeFrame: 0-12 hours, 90 days and 12 months after closed reduction
measure: Maximum pain in the affected wrist within the first 24 hours after closed reduction
timeFrame: 24-36 hours after the closed reduction.
measure: Proportion of patients with complex regional pain syndrome (CRPS)
timeFrame: 90 days and 12 months after closed reduction
measure: Disabilities of the Arm, Shoulder, and Hand (DASH) score
timeFrame: 90 days and 12 months after closed reduction
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: 12 months after closed reduction
measure: Quality of life (EQ-5D-5L) score
timeFrame: 90 days and 12 months after closed reduction
measure: Number of attempts used for closed reduction
timeFrame: Immediately after closed reduction
measure: Difficulty of closed reduction of the fracture
timeFrame: Immediately after closed reduction
measure: Discomfort related to the anaesthetic procedure
timeFrame: 0-12 hours after closed reduction
measure: Overall satisfaction with the treatment 0 to 24 hours after initiation of the anaesthesia
timeFrame: 24 hours after closed reduction
measure: Proportion of patients with unacceptable radiographic position at first follow-up in the orthopaedic out-patient clinic (typically 10-14 days post-reduction)
timeFrame: 10-14 days after closed reduction
measure: Proportion of individual complications in the composite secondary outcome
timeFrame: 90 days after closed reduction
measure: Proportion of patients having one or more serious adverse events (SAEs), including events related to loss of hand function
timeFrame: Within 90 days after closed reduction
measure: Proportion of patients having one or more adverse events (AEs)
timeFrame: Within 24 hours after closed reduction
Locations:
city: Hillerød
country: Denmark
facility: Copenhagen University Hospital - North Zealand Hillerød
state: Capital Region
Study officials:
affiliation: Copenhagen University Hospital - North Zealand
name: Cecilie D Harwood, MD, PhD-fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital - North Zealand
name: Anne-Sofie Jellestad, MD, PhD-fellow
role: PRINCIPAL_INVESTIGATOR
References: