Distal Radius FractureNCT05674383
Ultrasound Guided Axillary Nerve Block Compared to Hematoma Block in Patients With Closed Reposition of Distal Forearm Fractures
A study testing Axillary plexus nerve block and Fracture hematoma block in people with Distal Radius Fracture and Forearm Fracture, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Rationale: For distal forearm fractures the investigators propose an anaesthetic method using an ultrasound guided axillary nerve block (ANB, an established technique) for pain reduction during reposition dislocated fractures. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Radius Fracture, Forearm Fracture
- What is being tested?
- Axillary plexus nerve block and Fracture hematoma block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 28 Nov 2023
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients in the ED with a X-ray confirmed dislocated distal forearm fracture, defined as fracture < 3cm within the radiocarpal joint with an abnormal anatomic position (dorsal angulation >10°, volar angulation >20°, radioulnar inclination <15°, >5mm radial collapse or intra-articular incongruence >2mm.
- ≥ 16 years of age
- Patients who have adequate knowledge and understanding of the Dutch language
Who cannot join
- 'Open' fractures requiring surgery
- Multi-trauma patients
- Abnormal neurovascular examination requiring immediate reposition or surgery
- Pre-existent osteosynthesis material in situ on the present fracture site.
- Skin injury, local infection or recent burns hindering the use of ultrasound.
- Allergy for local anaesthetics
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- Inability to give informed consent (cognitive impairments, no good understanding of the Dutch or English language)
- Severe coagulopathy (i.e. severe thrombocytopenia, haemophilia.). Usage of anticoagulation is not an contra-indication, since any bleeding complication has few adverse consequences(20).
- High risk on compartment syndrome (in consultation with surgery department).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Medisch centrum Leeuwarden
Leeuwarden, Provincie Friesland, 8934AD
About this study
Official title: Ultrasound-guided Axillary Nerve Block Trial
Rationale: For distal forearm fractures the investigators propose an anaesthetic method using an ultrasound guided axillary nerve block (ANB, an established technique) for pain reduction during reposition dislocated fractures. Nowadays a fracture hematoma block (FHB) is common practice, but is suboptimal due to variability between performing physicians and is often experienced as a painful procedure. The investigators want to investigate if ANB is an effective, safe and efficient option in pain reduction in patients of an ED (emergency department) population with a distal forearm fracture.
Objective: To compare ultrasound-guided ANB with FHB for analgesia during reposition of non-operatively treated forearm fractures Study design: A randomized controlled trial. Study population: Patients ≥ 16 years of age with a closed, isolated and displaced distal forearm fracture requiring manipulative reposition.
Read more
Intervention (if applicable): The intervention group will receive an ANB on the ipsilateral arm of the fracture. The control group will get a FHB.
Main study parameters/endpoints: The primary outcome is pain score on a 11-point NRS (numeric rating scale) (0-10) during closed reposition of the dislocated distal forearm fracture in both groups. Main endpoint of this study is achieving a reduction of at least 2 points between both groups. This is considered as clinical relevant.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the research group are believed to have less pain and more comfort during reposition of the dislocated fracture. The investigators expect no other or more complications compared to standard care since the known complications are the same for both infiltrative anaesthetic interventions and are rare. Moreover, both procedures are common practice, therefore potential complications will be taken care of properly. The investigators expect there is no prolonged length of stay in the ED.
- Conditions
- Distal Radius Fracture, Forearm Fracture
- Being tested
- Axillary plexus nerve block, Fracture hematoma block
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axillary plexus nerve blockProcedure or surgery
Axillary plexus nerve block: an ultrasound-guided axillary plexus nerve block with a single injection of lidocaine 1%.
Fracture hematoma blockProcedure or surgery
Fracture hematoma block: a blinded single injection into the fracture with lidocaine 1%.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive an axillary plexus nerve block as pain reduction before the fracture repositioning. Receives: Procedure: Axillary plexus nerve block |
| Control group | Active comparator | The control group will receive a fracture hematoma block as pain reduction before the fracture repositioning. Receives: Procedure: Fracture hematoma block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
The primary outcome is pain measured on a pain score using a 11-point NRS (0-10) during closed reposition of the dislocated distal forearm fracture in both groups
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Jul 2021
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FractureStudies 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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bram Rook, Frisius Medisch Centrum
- Investigators
- Heleen Lameijer, Dr, Principal investigator, Heleen.Lameijer1@mcl.nl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674383
- Sponsor's protocol ID
- NL75603.099.20.
- Status last verified
- Nov 2023
- First submitted
- 21 Dec 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rook B, Bosch van den E, Haak SL, Have van der E, Edwards CM, Lameijer H. US-guided axillary nerve block vs. fracture hematoma block for forearm fracture analgesia in the ED: A randomised controlled trial. Am J Emerg Med. 2026 Feb;100:175-181. doi: 10.1016/j.ajem.2025.12.005. Epub 2025 Dec 7.
PubMed 41391425
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Axillary Nerve Block Trial
- ClinicalTrials.gov ID
- NCT05674383
- Acronym / sponsor ID
- NL75603.099.20.
- Conditions
- Distal Radius Fracture, Forearm Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 6 Jan 2023 (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.
Rationale: For distal forearm fractures the investigators propose an anaesthetic method using an ultrasound guided axillary nerve block (ANB, an established technique) for pain reduction during reposition dislocated fractures. Nowadays a fracture hematoma block (FHB) is common practice, but is suboptimal due to variability between performing physicians and is often experienced as a painful procedure. The investigators want to investigate if ANB is an effective, safe and efficient option in pain reduction in patients of an ED (emergency department) population with a distal forearm fracture.
Objective: To compare ultrasound-guided ANB with FHB for analgesia during reposition of non-operatively treated forearm fractures Study design: A randomized controlled trial. Study population: Patients ≥ 16 years of age with a closed, isolated and displaced distal forearm fracture requiring manipulative reposition.
Intervention (if applicable): The intervention group will receive an ANB on the ipsilateral arm of the fracture. The control group will get a FHB.
Main study parameters/endpoints: The primary outcome is pain score on a 11-point NRS (numeric rating scale) (0-10) during closed reposition of the dislocated distal forearm fracture in both groups. Main endpoint of this study is achieving a reduction of at least 2 points between both groups. This is considered as clinical relevant.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients participating in the research group are believed to have less pain and more comfort during reposition of the dislocated fracture. The investigators expect no other or more complications compared to standard care since the known complications are the same for both infiltrative anaesthetic interventions and are rare. Moreover, both procedures are common practice, therefore potential complications will be taken care of properly. The investigators expect there is no prolonged length of stay in the ED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Axillary plexus nerve blockThe intervention group will receive an axillary plexus nerve block as pain reduction before the fracture repositioning. |
| Control group | Active comparator | Procedure: Fracture hematoma blockThe control group will receive a fracture hematoma block as pain reduction before the fracture repositioning. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in the ED with a X-ray confirmed dislocated distal forearm fracture, defined as fracture < 3cm within the radiocarpal joint with an abnormal anatomic position (dorsal angulation >10°, volar angulation >20°, radioulnar inclination <15°, >5mm radial collapse or intra-articular incongruence >2mm.
- ≥ 16 years of age
- Patients who have adequate knowledge and understanding of the Dutch language
Key exclusion criteria (9 listed)
- 'Open' fractures requiring surgery
- Multi-trauma patients
- Abnormal neurovascular examination requiring immediate reposition or surgery
- Pre-existent osteosynthesis material in situ on the present fracture site.
- Skin injury, local infection or recent burns hindering the use of ultrasound.
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 |
|---|---|---|
| Axillary plexus nerve blockAxillary plexus nerve block: an ultrasound-guided axillary plexus nerve block with a single injection of lidocaine 1%. | Procedure or surgery | Intervention group |
| Fracture hematoma blockFracture hematoma block: a blinded single injection into the fracture with lidocaine 1%. | Procedure or surgery | Control group |
Primary outcome
Pain score
Time frame: 15 minutes
The primary outcome is pain measured on a pain score using a 11-point NRS (0-10) during closed reposition of the dislocated distal forearm fracture in both groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 41391425Rook B, Bosch van den E, Haak SL, Have van der E, Edwards CM, Lameijer H. US-guided axillary nerve block vs. fracture hematoma block for forearm fracture analgesia in the ED: A randomised controlled trial. Am J Emerg Med. 2026 Feb;100:175-181. doi: 10.1016/j.ajem.2025.12.005. Epub 2025 Dec 7.
- 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.
Heleen Lameijer, Dr principal investigator
Heleen.Lameijer1@mcl.nl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axillary plexus nerve block and Fracture hematoma block in people with Distal Radius Fracture and Forearm Fracture, 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 29 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674383, which also lists 1 linked publication.
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 29 Nov 2023.