Ultrasound Guided Hematoma Block in Distal Radius Fractures

NCT06193915 | Recruiting

• 1 other identifier: 20230041
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Distal radius fracture; Ultrasound; Hematoma block

Outcome Measures

Primary Outcomes (1)

• Effectiveness of analgesia during closed reduction of a distal radius fracture

  Pain reduction will be measured on a Numeric Rating Scale( NRS-scale; 0-10) at different moments

  NRS before, during and after (10-15 min) injection of hematoma block, NRS-score during closed reduction and after closed reduction (5 min)

Secondary Outcomes (11)

• Number of participants in which hematoma was aspirated during hematoma block

  During hematoma block

• Procedural time of the Hematoma block

  Time from insertion of the needle until needle is withdrawn out of the patient (up to maximum of 30 min.)

• Procedural time of the reduction

  From moment physician is ready to start the reduction until cast is applied (up to maximum of 30 min.)

• Satisfaction of the HB provided by physician performing the HB procedure

  10-15 minutes after hematoma block

• Satisfaction of reduction provided by physician performing reduction measured

  10-15 minutes after closed reduction

Study Arms (2)

Ultrasound guided hematoma block

EXPERIMENTAL

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

Device: Ultrasound guided hematoma block.

Blind hematoma block

ACTIVE COMPARATOR

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

Procedure: Blind hematoma block

Interventions

Ultrasound guided hematoma block. 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.

Ultrasound guided hematoma block

Blind hematoma block 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.

Blind hematoma block

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead

Study Sites (1)

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Fracture Dislocation

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Joint Dislocations; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Pieter Veenstra

  Medisch Centrum Leeuwarden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pieter Veenstra

CONTACT

(058) 286 3852; pieter.veenstra@mcl.nl

Heleen Lameijer

CONTACT

(058) 286 3112; heleen.lameijer@mcl.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because treatment in both groups are different (one group with and one group without ultrasound) it's not possible to mask the treating physician for the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: January 5, 2024
• Study Start: January 5, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)