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This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guided hematoma block | Experimental | Patients in this group will receive ultrasound guided hematoma block before reduction of their dislocated distal radius fracture. |
|
| Blind hematoma block | Active Comparator | Patients in this group will receive standard treatment; hematoma block with palpation of the fracture site (blind hematoma block) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Procedural time of the Hematoma block |
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Inclusion Criteria:
Age ≥ 16 years
Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pieter Veenstra | Contact | (058) 286 3852 | pieter.veenstra@mcl.nl | |
| Heleen Lameijer | Contact | (058) 286 3112 | heleen.lameijer@mcl.nl |
| Name | Affiliation | Role |
|---|---|---|
| Pieter Veenstra | Medisch Centrum Leeuwarden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medisch Centrum Leeuwarden | Recruiting | Leeuwarden | Provincie Friesland | 8934AD | Netherlands |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D000072039 | Fracture Dislocation |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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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.
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|
| 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. |
|
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.) |
| 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.) |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of reductions | Defined as attempt(s) to align fracture and application of cast | (up to) 10-15 minutes after last closed reduction attempt |
| 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 |
| 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 |
| 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 |
| D004204 |
| Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |