Distal Radius FracturesNCT06193915
Ultrasound Guided Hematoma Block in Distal Radius Fractures
A study testing Ultrasound guided hematoma block. and Blind hematoma block in people with Distal Radius Fractures and Fracture Dislocation, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Distal Radius Fractures, Fracture Dislocation, Dislocated Wrist
- What is being tested?
- Ultrasound guided hematoma block. and Blind hematoma block
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Jan 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- >15 degrees radial inclination;
- Translation and non-intact radio-carpal alignment in the lateral view
- Significant translation in the posterior-anterior(PA)-view.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Medisch Centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934AD
Pieter Veenstra, pieter.veenstra@mcl.nl
About this study
Official title: Ultrasound Guided Hematoma Block vs. Blind Hematoma Block in Distal Radius Fractures, a Randomized Controlled Trial
This study will investigate the effectiveness of analgesia of ultrasound hematoma block compared to 'blind' hematoma block in patients with dislocated distal radius fracture.
Read the 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.
- Being tested
- Ultrasound guided hematoma block., Blind hematoma block
- Keywords
- Distal radius fracture, Ultrasound, Hematoma block
- Medical subject headings
- Wrist Fractures, Fracture Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Blind hematoma blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided hematoma block | Experimental | Patients in this group will receive ultrasound guided hematoma block before reduction of their dislocated distal radius fracture. Receives: Device: Ultrasound guided hematoma block. |
| Blind hematoma block | Active comparator | Patients in this group will receive standard treatment; hematoma block with palpation of the fracture site (blind hematoma block) Receives: Procedure: Blind hematoma block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (11)
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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 10-15 minutes after closed reduction
Number of reductions
Defined as attempt(s) to align fracture and application of cast
Measured: (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.
Measured: (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.
Measured: (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)
Measured: During performing hematoma block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start5 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pieter Veenstra, Frisius Medisch Centrum
- Investigators
- Pieter Veenstra, Principal investigator, Medisch Centrum Leeuwarden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193915
- Sponsor's protocol ID
- 20230041
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2023
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Hematoma Block vs. Blind Hematoma Block in Distal Radius Fractures, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06193915
- Acronym / sponsor ID
- 20230041
- Keywords
- Distal radius fracture, Ultrasound, Hematoma block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided hematoma block | Experimental | Device: Ultrasound guided hematoma block.Patients in this group will receive ultrasound guided hematoma block before reduction of their dislocated distal radius fracture. |
| Blind hematoma block | Active comparator | Procedure: Blind hematoma blockPatients in this group will receive standard treatment; hematoma block with palpation of the fracture site (blind hematoma block) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 16 years
- Confirmed fracture of the distal radius requiring closed reduction, defined as any off the following items(7):
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound 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. | Device | Ultrasound guided hematoma block |
| Blind hematoma blockPatients 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. | Procedure or surgery | Blind hematoma block |
Primary outcome
Effectiveness of analgesia during closed reduction of a distal radius fracture
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)
Pain reduction will be measured on a Numeric Rating Scale( NRS-scale; 0-10) at different moments
11 secondary outcomes
Number of participants in which hematoma was aspirated during hematoma block
Time frame: During hematoma block
Procedural time of the Hematoma block
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 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
Time frame: 10-15 minutes after hematoma block
Satisfaction of reduction provided by physician performing reduction measured
Time frame: 10-15 minutes after closed reduction
Satisfaction of the patient for procedure and reduction
Time frame: 10-15 minutes after closed reduction
Satisfaction of the nurse for procedure and reduction
Time frame: 10-15 minutes after closed reduction
Number of reductions
Time frame: (up to) 10-15 minutes after last closed reduction attempt
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.
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
Time frame: During performing hematoma block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pieter Veenstra principal investigator
Medisch Centrum Leeuwarden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided hematoma block. and Blind hematoma block in people with Distal Radius Fractures and Fracture Dislocation, run by Frisius Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pieter Veenstra ((058) 286 3852, pieter.veenstra@mcl.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of analgesia during closed reduction of a distal radius fracture (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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.