Ultrasound Guided Hematoma Block in Distal Radius Fractures

NCT ID: NCT06193915

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-05
• Study Completion Date: 2024-12-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultrasound guided hematoma block

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

Group Type: EXPERIMENTAL

Ultrasound guided hematoma block.

Intervention Type: DEVICE

Patients with a dislocated fracture of the distal radius will receive ultrasound guided hematoma block with 10mL lidocaine 2% to get real-time guidance of the given anesthesia into the fracture site before closed reduction of a distal radius fracture.

Blind hematoma block

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

Group Type: ACTIVE_COMPARATOR

Blind hematoma block

Intervention Type: PROCEDURE

Patients with a distal radius fracture will receive standard treatment; hematoma block with 10mL 2% lidocaine performed with palpation of the fracture site (blind hematoma block) before closed reduction of dislocated distal radius fractures.

Interventions

Ultrasound guided hematoma block.

Patients with a dislocated fracture of the distal radius will receive ultrasound guided hematoma block with 10mL lidocaine 2% to get real-time guidance of the given anesthesia into the fracture site before closed reduction of a distal radius fracture.

Intervention Type: DEVICE

Blind hematoma block

Patients with a distal radius fracture will receive standard treatment; hematoma block with 10mL 2% lidocaine performed with palpation of the fracture site (blind hematoma block) before closed reduction of dislocated distal radius fractures.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Frisius Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Pieter Veenstra

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pieter Veenstra

Role: PRINCIPAL_INVESTIGATOR

Medisch Centrum Leeuwarden

Locations

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Pieter Veenstra

Role: CONTACT

pieter.veenstra@mcl.nl

(058) 286 3852

Heleen Lameijer

Role: CONTACT

heleen.lameijer@mcl.nl

(058) 286 3112

Facility Contacts

Pieter Veenstra

Role: primary

pieter.veenstra@mcl.nl

Other Identifiers

20230041

Identifier Type: -

Identifier Source: org_study_id