Clinical trial NCT06193915: Ultrasound Guided Hematoma Block in Distal Radius Fractures
Official title: Ultrasound Guided Hematoma Block vs. Blind Hematoma Block in Distal Radius Fractures, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fractures
Fracture Dislocation
Dislocated Wrist
Dislocated Radius
Keywords: Distal radius fracture
Ultrasound
Hematoma block
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Effectiveness of analgesia during closed reduction of a distal radius fracture
timeFrame: 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:
measure: Number of participants in which hematoma was aspirated during hematoma block
timeFrame: During hematoma block
measure: Procedural time of the Hematoma block
timeFrame: Time from insertion of the needle until needle is withdrawn out of the patient (up to maximum of 30 min.)
measure: Procedural time of the reduction
timeFrame: From moment physician is ready to start the reduction until cast is applied (up to maximum of 30 min.)
measure: Satisfaction of the HB provided by physician performing the HB procedure
timeFrame: 10-15 minutes after hematoma block
measure: Satisfaction of reduction provided by physician performing reduction measured
timeFrame: 10-15 minutes after closed reduction
measure: Satisfaction of the patient for procedure and reduction
timeFrame: 10-15 minutes after closed reduction
measure: Satisfaction of the nurse for procedure and reduction
timeFrame: 10-15 minutes after closed reduction
measure: Number of reductions
timeFrame: (up to) 10-15 minutes after last closed reduction attempt
measure: Years of experience of treating physician in performing HB.
timeFrame: (up to) 10-15 minutes after last closed reduction attempt
measure: Years of experience of treating physician with use of ultrasound.
timeFrame: (up to) 10-15 minutes after last closed reduction attempt
measure: Number of patients in which palpation of an evident step-off near fracture site was felt
timeFrame: During performing hematoma block
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
state: Friesland
Study officials:
affiliation: Medisch Centrum Leeuwarden
name: Pieter Veenstra
role: PRINCIPAL_INVESTIGATOR
References: