An interventional study of Ultrasound guided hematoma block. and Blind hematoma block in Distal Radius Fractures, Fracture Dislocation and Dislocated Wrist, sponsored by Medical Centre Leeuwarden. Recruiting at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Medical Centre Leeuwarden · Not applicable, Interventional, and Treatment
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.
330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 265 interventional studies indexed under Wrist Fractures.
Browse Wrist Fractures studies →Medical Centre Leeuwarden is the lead sponsor of 41 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will receive ultrasound guided hematoma block before reduction of their dislocated distal radius fracture.
Device: Ultrasound guided hematoma block.
Patients in this group will receive standard treatment; hematoma block with palpation of the fracture site (blind hematoma block)
Procedure: Blind 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.
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.
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
Time frame: NRS before, during and after (10-15 min) injection of hematoma block, NRS-score during closed reduction and after closed reduction (5 min)
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)
Time frame: During hematoma block
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 frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 10-15 minutes after closed reduction
Number of reductions
Defined as attempt(s) to align fracture and application of cast
Time frame: (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.
Time frame: (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.
Time frame: (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)
Time frame: During performing hematoma block
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2024, 11 months after the start.
Of 125 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 11 months is below that.
Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 16 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical Centre Leeuwarden