Ultrasound Guided Hematoma Block in Distal Radius Fractures

Medical Centre Leeuwarden

Status: Enrolling

Conditions: Dislocated Radius; Distal Radius Fractures; Dislocated Wrist; Fracture Dislocation

Treatments: Procedure: Blind hematoma block; Device: Ultrasound guided hematoma block.

Study type: Interventional

Funder types: Other

Identifiers

NCT06193915

20230041

Details and patient eligibility

About

This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.

Full description

Distal radius fractures represent one of the most common injuries in the Emergency Department (ED). Proper treatment especially for dislocated fractures can minimize the chance of residual injury. For closed reduction anesthesia is essential for safety, satisfaction and result. Different methods of regional anesthesia can be used but hematoma block (HB) is the technique most often used in EDs in the Netherlands and recommended by Dutch guidelines. In practice however a HB, does not always lead to adequate anesthesia, this might be because of poor infiltration into the fracture site. Ultrasound could additionally provide real-time guidance of injection into the fracture site, maximizing the analgesic effect of HB. In this study the effectiveness of analgesia of ultrasound HB will be compared to 'blind' HB in patients with a dislocated distal radius fracture.

Patients with a confirmed dislocated fracture of the distal radius requiring closed reduction will be randomized to either ultrasound guided hematoma block or normal 'blind' hematoma block. NRS-scores will be given before, during and after hematoma block and during and after reduction of the fracture. These scores will be the primary endpoint of this study.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 16 years

• Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):

  • >10 degrees of dorsal angulation;
  • >20 degrees of volar angulation;
  • >2 mm step-off intra-articular;
  • >3 mm radial shortening;
  • >15 degrees radial inclination;
  • Translation and non-intact radio-carpal alignment in the lateral view
  • Significant translation in the posterior-anterior(PA)-view.

Exclusion criteria

• No informed consent can be given (cognitive impairment, severe dementia, no knowledge of Dutch language e.a.)
• Neurovascular compromise or open fractures requiring (immediate) surgery or reduction.
• First reduction already performed
• Multi-trauma patients requiring other urgent procedures/tests or with respiratory or hemodynamical compromise
• Pre-existent osteosynthesis material in situ in the affected arm
• Skin injury (with exception of minor abrasions), local infection or recent burns hindering or contra-indicating the use of ultrasound and ultrasound gel
• Allergy for local anesthetics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Ultrasound guided hematoma block

Experimental group

Description:

Patients in this group will receive ultrasound guided hematoma block before reduction of their dislocated distal radius fracture.

Treatment:

Device: Ultrasound guided hematoma block.

Blind hematoma block

Active Comparator group

Description:

Patients in this group will receive standard treatment; hematoma block with palpation of the fracture site (blind hematoma block)

Treatment:

Procedure: Blind hematoma block