Ultrasound Guided Hematoma Block in Distal Radius Fractures

Last updated: March 16, 2024
Sponsor: Medical Centre Leeuwarden
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

Blind hematoma block

Ultrasound guided hematoma block.

Clinical Study ID

NCT06193915
20230041
  • Ages > 16
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 16 years
  • Confirmed fracture of the distal radius requiring closed reduction, defined as any offthe 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

Exclusion Criteria:

  • No informed consent can be given (cognitive impairment, severe dementia, no knowledgeof 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 orhemodynamical compromise
  • Pre-existent osteosynthesis material in situ in the affected arm
  • Skin injury (with exception of minor abrasions), local infection or recent burnshindering or contra-indicating the use of ultrasound and ultrasound gel
  • Allergy for local anesthetics

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Blind hematoma block
Phase:
Study Start date:
January 05, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Medisch Centrum Leeuwarden

    Leeuwarden, Friesland 8934AD
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.