Dislocated Radius, Dislocated Wrist, Distal Radius Fractures, Fracture Dislocation
Conditions
Keywords
Distal radius fracture, Ultrasound, Hematoma block
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.
Interventions
DEVICEUltrasound 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.
PROCEDUREBlind 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.
Sponsors
Frisius Medisch Centrum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of analgesia during closed reduction of a distal radius fracture | NRS before, during and after (10-15 min) injection of hematoma block, NRS-score during closed reduction and after closed reduction (5 min) | Pain reduction will be measured on a Numeric Rating Scale( NRS-scale; 0-10) at different moments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Years of experience of treating physician with use of ultrasound. | (up to) 10-15 minutes after last closed reduction attempt | Years of experience of treating physician with use of ultrasound. |
| Number of patients in which palpation of an evident step-off near fracture site was felt | During performing hematoma block | 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) |
| Number of participants in which hematoma was aspirated during hematoma block | During hematoma block | Measure of correct position of hematoma block if there is aspiration of blood (yes/no) |
| 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.) | 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) |
| Procedural time of the reduction | From moment physician is ready to start the reduction until cast is applied (up to maximum of 30 min.) | Time needed to perform reduction of the fracture |
| Years of experience of treating physician in performing HB. | (up to) 10-15 minutes after last closed reduction attempt | Years of experience of treating physician in performing HB. |
| Satisfaction of reduction provided by physician performing reduction measured | 10-15 minutes after closed reduction | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) |
| Satisfaction of the patient for procedure and reduction | 10-15 minutes after closed reduction | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) |
| Satisfaction of the nurse for procedure and reduction | 10-15 minutes after closed reduction | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) |
| Number of reductions | (up to) 10-15 minutes after last closed reduction attempt | Defined as attempt(s) to align fracture and application of cast |
| Satisfaction of the HB provided by physician performing the HB procedure | 10-15 minutes after hematoma block | measured on a 5-points Likert-scale (Very satisfied, Somewhat satisfied, Neither satisfied nor dissatisfied, Somewhat dissatisfied or Very dissatisfied) |
Countries
Netherlands
Contacts
Primary ContactPieter Veenstra
Backup ContactHeleen Lameijer
Outcome results
None listed