Distal Radius Fractures Clinical Trial
Official title:
Ultrasound Guided Hematoma Block vs. Blind Hematoma Block in Distal Radius Fractures, a Randomized Controlled Trial
NCT number | NCT06193915 |
Other study ID # | 20230041 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 5, 2024 |
Est. completion date | December 2024 |
This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | Friesland |
Lead Sponsor | Collaborator |
---|---|
Medical Centre Leeuwarden |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of participants in which hematoma was aspirated during hematoma block | Measure of correct position of hematoma block if there is aspiration of blood (yes/no) | During hematoma block | |
Secondary | Procedural time of the Hematoma block | Time needed to perform HB (blind or ultrasound-guided; from moment of localization of the fracture until the moment the needle is out of the patient) | Time from insertion of the needle until needle is withdrawn out of the patient (up to maximum of 30 min.) | |
Secondary | Procedural time of the reduction | Time needed to perform reduction of the fracture | From moment physician is ready to start the reduction until cast is applied (up to maximum of 30 min.) | |
Secondary | Satisfaction of the HB provided by physician performing the HB procedure | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) | 10-15 minutes after hematoma block | |
Secondary | Satisfaction of reduction provided by physician performing reduction measured | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) | 10-15 minutes after closed reduction | |
Secondary | Satisfaction of the patient for procedure and reduction | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) | 10-15 minutes after closed reduction | |
Secondary | Satisfaction of the nurse for procedure and reduction | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) | 10-15 minutes after closed reduction | |
Secondary | Number of reductions | Defined as attempt(s) to align fracture and application of cast | (up to) 10-15 minutes after last closed reduction attempt | |
Secondary | Years of experience of treating physician in performing HB. | Years of experience of treating physician in performing HB. | (up to) 10-15 minutes after last closed reduction attempt | |
Secondary | Years of experience of treating physician with use of ultrasound. | Years of experience of treating physician with use of ultrasound. | (up to) 10-15 minutes after last closed reduction attempt | |
Secondary | Number of patients in which palpation of an evident step-off near fracture site was felt | Before performing hematoma block performing physician will palpate if there is a clear step-off near the fracture site (important especially in blind hematoma group) | During performing hematoma block |
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