Wrist FracturePhase 4NCT07268547
Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)
A Phase 4 study testing Supracondylar radial nerve block, Hematoma block and Combination of blocks in people with Wrist Fracture, run by Sarasota Memorial Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Fracture
- What is being tested?
- Supracondylar radial nerve block, Hematoma block and Combination of blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Patients admitted to the ECC with a distal radius fracture requiring closed reduction
- Patient must be willing and able to provide informed consent to the study
Who cannot join
- Under 18 years of age
- Pregnant
- Prisoner
- Allergy to lidocaine
- Patients unable to provide informed consent and/or perform study-related activities
- Patients undergoing procedural sedation
- Patients may be excluded at the discretion of the investigator based on their clinical judgment, if the participant no longer meets criteria, and/or if the health or safety of the patient may be impacted by taking part in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
About this study
The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture). This is being done to find out which method provides better pain relief after the injury and during treatment in the emergency room.
Read the detailed description
This study is testing different ways to provide pain relief before reducing a broken wrist. Participants will receive one of three techniques: (1) a nerve block where a doctor injects lidocaine near the radial nerve under ultrasound guidance; (2) a hematoma block where a doctor injects lidocaine into the area where the bone broke; or (3) both the nerve block and the hematoma block. Patients will be asked how much pain they feel before the numbing, after the numbing, and after the wrist is reduced.
- Conditions
- Wrist Fracture
- Being tested
- Supracondylar radial nerve block, Hematoma block, Combination of blocks
- Keywords
- wrist fracture, fracture, nerve block
- Medical subject headings
- Wrist Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supracondylar radial nerve blockProcedure or surgery
Supracondylar radial nerve blocks given at the radial nerve not as the same location of the fracture site, prior to fracture reduction.
Hematoma blockProcedure or surgery
Injection of analgesia into the hematoma that forms surrounding the wrist fracture.
Combination of blocksProcedure or surgery
Supracondylar radial nerve block given first, followed by hematoma block, before fracture reduction.
| Study group | Role | What they receive |
|---|---|---|
| Supracondylar radial nerve blocks | Experimental | Lidocaine injection given near the radial never under ultrasound guidance Receives: Procedure: Supracondylar radial nerve block |
| Hematoma blocks | Experimental | Injecting analgesia into the hematoma that forms surrounding the wrist fracture Receives: Procedure: Hematoma block |
| Combination of supracondylar radial nerve block and hematoma block | Experimental | Supracondylar radial nerve block given first followed by hematoma block Receives: Procedure: Combination of blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain levels comparison
Comparing pain levels among patients who are undergoing a wrist fracture reduction. Measured on a scale of 0-10, 0= no pain to 10= worst pain.
Pain will be measured at (1) baseline, (2) after administering the assigned pain block (s), and after the (3) fracture reduction.
Measured: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.
Secondary outcomes (3)
Amount of opioid medication needed to control pain.
The amount of opioid prescribed, if any, will be collected and recorded for comparison during patient's time in emergency room.
Measured: Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.
Number of patients requiring conscious sedation.
The need for conscious sedation among patients undergoing wrist fracture reduction in emergency care center will be recorded and monitored for comparison between groups.
Measured: Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.
Adverse Events Monitoring
Adverse events associated with any of the blocks that are administered to patients undergoing a wrist fracture reduction in the emergency care center will be identified, monitored, and recorded for reporting.
Measured: From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start9 Dec 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Wrist 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for lowering pain in people with a broken wrist (distal radius fracture). We want to find out which method provides better pain relief after the injury and during treatment in the emergency room. Each of these methods is a different standard procedure for pain control prior to wrist fracture reduction.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarasota Memorial Health Care System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Glaze, DO, Sarasota Memorial Health Care System
- Investigators
- Danielle Glaze, DO, Principal investigator, Sarasota Memorial Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268547
- Sponsor's protocol ID
- 25-MEDI-58
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tseng PT, Leu TH, Chen YW, Chen YP. Hematoma block or procedural sedation and analgesia, which is the most effective method of anesthesia in reduction of displaced distal radius fracture? J Orthop Surg Res. 2018 Mar 27;13(1):62. doi: 10.1186/s13018-018-0772-7.
PubMed 29580286Siebelt M, Hartholt KA, van Winden DFM, Boot F, Papathanasiou D, Verdouw BC, de Vries MR, Mathijssen NM, Kraan GA. Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials. J Orthop Trauma. 2019 Apr;33(4):e124-e130. doi: 10.1097/BOT.0000000000001388.
PubMed 30893220Oakley B, Busby C, Kulkarni S, Arnold SJ, Kulkarni SS, Ollivere BJ. Manipulation of distal radius fractures: a comparison of Bier's block vs haematoma block. Ann R Coll Surg Engl. 2023 May;105(5):434-440. doi: 10.1308/rcsann.2022.0116. Epub 2022 Oct 14.
PubMed 36239973Maia GAS, Cunha JC, Feijo CQ, Leal DM, Moreira JJ, Herrero CFPDS. Radial Nerve Supracondylar Block Versus Fracture Hematoma Block. Comparison of Their Efficacy in Cases of Fractures of the Distal Third of the Radius. Rev Bras Ortop (Sao Paulo). 2023 Aug 30;58(4):e557-e562. doi: 10.1055/s-0043-1768623. eCollection 2023 Aug.
PubMed 37663190Handoll HH, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane Database Syst Rev. 2002;2002(3):CD003320. doi: 10.1002/14651858.CD003320.
PubMed 12137688Haley CB, Beauchesne AR, Fox JC, Nelson AM. Block Time: A Multispecialty Systematic Review of Efficacy and Safety of Ultrasound-guided Upper Extremity Nerve Blocks. West J Emerg Med. 2023 Jun 30;24(4):774-785. doi: 10.5811/westjem.56058.
PubMed 37527380Gottlieb M, Cosby K. Ultrasound-guided hematoma block for distal radial and ulnar fractures. J Emerg Med. 2015 Mar;48(3):310-2. doi: 10.1016/j.jemermed.2014.09.063. Epub 2014 Dec 9.
PubMed 25497895Martinez-Arboleda JJ, Moreno M, Diaz-Solorzano JP, Mejia-Grueso A. Ultrasound-guided supracondylar radial nerve block for closed reduction of a distal radius fracture in the emergency department: Case report. Trauma Case Rep. 2024 Sep 25;54:101116. doi: 10.1016/j.tcr.2024.101116. eCollection 2024 Dec.
PubMed 39399762Che Daud AZ, Mohd Nayan NA, Ahmad A, Alrashdi M, Kadar M, Mohd Poot EF. Distal radius fracture rehabilitation: A bibliometric and scoping review. J Hand Ther. 2026 Jan-Mar;39(1):120-132. doi: 10.1016/j.jht.2025.05.016. Epub 2025 Jul 4.
PubMed 40615307Abbasi S, Garjani N, Mahshidfar B, Farsi D, Mofidi M, Hafezimoghadam P, Rezai M, Javan A. Comparative Study of Radial and Median Nerve Blocks with Hematoma Block under Ultrasound Guide in Distal Radius Fracture Reduction: A Randomized Clinical Trial. Med J Islam Repub Iran. 2023 Oct 23;37:113. doi: 10.47176/mjiri.37.113. eCollection 2023.
PubMed 38145179
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wrist Reduction Intervention: Supracondylar Technique for Radial Nerve Block vs. Hematoma Block (WRIST Block Study)
- ClinicalTrials.gov ID
- NCT07268547
- Acronym / sponsor ID
- 25-MEDI-58
- Conditions
- Wrist Fracture
- Keywords
- wrist fracture, fracture, nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Sarasota Memorial Health Care SystemUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 5 Dec 2025 (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.
The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for reducing pain in people with a broken wrist (distal radius fracture). This is being done to find out which method provides better pain relief after the injury and during treatment in the emergency room.
Detailed description
This study is testing different ways to provide pain relief before reducing a broken wrist. Participants will receive one of three techniques: (1) a nerve block where a doctor injects lidocaine near the radial nerve under ultrasound guidance; (2) a hematoma block where a doctor injects lidocaine into the area where the bone broke; or (3) both the nerve block and the hematoma block. Patients will be asked how much pain they feel before the numbing, after the numbing, and after the wrist is reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The purpose of this study is to compare different types of local anesthesia-a supracondylar radial nerve block, a hematoma block, or a combination of the two-for lowering pain in people with a broken wrist (distal radius fracture). We want to find out which method provides better pain relief after the injury and during treatment in the emergency room. Each of these methods is a different standard procedure for pain control prior to wrist fracture reduction.
| Arm | Type | Receives |
|---|---|---|
| Supracondylar radial nerve blocks | Experimental | Procedure: Supracondylar radial nerve blockLidocaine injection given near the radial never under ultrasound guidance |
| Hematoma blocks | Experimental | Procedure: Hematoma blockInjecting analgesia into the hematoma that forms surrounding the wrist fracture |
| Combination of supracondylar radial nerve block and hematoma block | Experimental | Procedure: Combination of blocksSupracondylar radial nerve block given first followed by hematoma block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients admitted to the ECC with a distal radius fracture requiring closed reduction
- Patient must be willing and able to provide informed consent to the study
Key exclusion criteria (7 listed)
- Under 18 years of age
- Pregnant
- Prisoner
- Allergy to lidocaine
- Patients unable to provide informed consent and/or perform study-related activities
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 |
|---|---|---|
| Supracondylar radial nerve blockSupracondylar radial nerve blocks given at the radial nerve not as the same location of the fracture site, prior to fracture reduction. | Procedure or surgery | Supracondylar radial nerve blocks |
| Hematoma blockInjection of analgesia into the hematoma that forms surrounding the wrist fracture. | Procedure or surgery | Hematoma blocks |
| Combination of blocksSupracondylar radial nerve block given first, followed by hematoma block, before fracture reduction. | Procedure or surgery | Combination of supracondylar radial nerve block and hematoma block |
Primary outcome
Pain levels comparison
Time frame: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.
Comparing pain levels among patients who are undergoing a wrist fracture reduction. Measured on a scale of 0-10, 0= no pain to 10= worst pain. Pain will be measured at (1) baseline, (2) after administering the assigned pain block (s), and after the (3) fracture reduction.
3 secondary outcomes
Amount of opioid medication needed to control pain.
Time frame: Opioid medication prescribing will be assessed at baseline, time of admission to the emergency room, until the patient is discharged and they are no longer active in the study.
Number of patients requiring conscious sedation.
Time frame: Patients will be monitored for need of conscious sedation from baseline, time of enrollment in the study, until discharge from the emergency room, when they are no longer active in the study.
Adverse Events Monitoring
Time frame: From baseline, time the patient is admitted and enrolled into the study, until the patient is discharged and no longer active in the study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 29580286Tseng PT, Leu TH, Chen YW, Chen YP. Hematoma block or procedural sedation and analgesia, which is the most effective method of anesthesia in reduction of displaced distal radius fracture? J Orthop Surg Res. 2018 Mar 27;13(1):62. doi: 10.1186/s13018-018-0772-7.
- Background: PubMed 30893220Siebelt M, Hartholt KA, van Winden DFM, Boot F, Papathanasiou D, Verdouw BC, de Vries MR, Mathijssen NM, Kraan GA. Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials. J Orthop Trauma. 2019 Apr;33(4):e124-e130. doi: 10.1097/BOT.0000000000001388.
- Background: PubMed 36239973Oakley B, Busby C, Kulkarni S, Arnold SJ, Kulkarni SS, Ollivere BJ. Manipulation of distal radius fractures: a comparison of Bier's block vs haematoma block. Ann R Coll Surg Engl. 2023 May;105(5):434-440. doi: 10.1308/rcsann.2022.0116. Epub 2022 Oct 14.
- Background: PubMed 37663190Maia GAS, Cunha JC, Feijo CQ, Leal DM, Moreira JJ, Herrero CFPDS. Radial Nerve Supracondylar Block Versus Fracture Hematoma Block. Comparison of Their Efficacy in Cases of Fractures of the Distal Third of the Radius. Rev Bras Ortop (Sao Paulo). 2023 Aug 30;58(4):e557-e562. doi: 10.1055/s-0043-1768623. eCollection 2023 Aug.
- Background: PubMed 12137688Handoll HH, Madhok R, Dodds C. Anaesthesia for treating distal radial fracture in adults. Cochrane Database Syst Rev. 2002;2002(3):CD003320. doi: 10.1002/14651858.CD003320.
- Background: PubMed 37527380Haley CB, Beauchesne AR, Fox JC, Nelson AM. Block Time: A Multispecialty Systematic Review of Efficacy and Safety of Ultrasound-guided Upper Extremity Nerve Blocks. West J Emerg Med. 2023 Jun 30;24(4):774-785. doi: 10.5811/westjem.56058.
- Background: PubMed 25497895Gottlieb M, Cosby K. Ultrasound-guided hematoma block for distal radial and ulnar fractures. J Emerg Med. 2015 Mar;48(3):310-2. doi: 10.1016/j.jemermed.2014.09.063. Epub 2014 Dec 9.
- Background: PubMed 39399762Martinez-Arboleda JJ, Moreno M, Diaz-Solorzano JP, Mejia-Grueso A. Ultrasound-guided supracondylar radial nerve block for closed reduction of a distal radius fracture in the emergency department: Case report. Trauma Case Rep. 2024 Sep 25;54:101116. doi: 10.1016/j.tcr.2024.101116. eCollection 2024 Dec.
- Background: PubMed 40615307Che Daud AZ, Mohd Nayan NA, Ahmad A, Alrashdi M, Kadar M, Mohd Poot EF. Distal radius fracture rehabilitation: A bibliometric and scoping review. J Hand Ther. 2026 Jan-Mar;39(1):120-132. doi: 10.1016/j.jht.2025.05.016. Epub 2025 Jul 4.
- Background: PubMed 38145179Abbasi S, Garjani N, Mahshidfar B, Farsi D, Mofidi M, Hafezimoghadam P, Rezai M, Javan A. Comparative Study of Radial and Median Nerve Blocks with Hematoma Block under Ultrasound Guide in Distal Radius Fracture Reduction: A Randomized Clinical Trial. Med J Islam Repub Iran. 2023 Oct 23;37:113. doi: 10.47176/mjiri.37.113. eCollection 2023.
- 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.
Danielle Glaze, DO principal investigator
Sarasota Memorial Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Supracondylar radial nerve block, Hematoma block and Combination of blocks in people with Wrist Fracture, run by Sarasota Memorial Health Care System at 1 site in United States.
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 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 levels comparison (time frame: Pain will be measured at (1) baseline, (2) after administering the assigned pain block(s), and after the (3) fracture reduction.). 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 NCT07268547, which also lists 10 linked publications.
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 26 Oct 2026.