Acute Distal Radius FractureBRAVENCT07183904
Nerve and Hematoma Blocks for Pain Relief During Distal Radius Fracture Reduction
A study testing Hematoma Block and Median Nerve Block in people with Acute Distal Radius Fracture and Displaced Distal Radius Fracture, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
Distal radius fractures, commonly known as wrist fractures, are among the most frequent injuries seen in emergency departments. These injuries often require a closed reduction, a procedure in which the broken bone is manipulated back into place without surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Distal Radius Fracture, Displaced Distal Radius Fracture
- What is being tested?
- Hematoma Block and Median Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 5 Mar 2025
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 100 years.
- Diagnosis of acute displaced distal radius fracture (< 48 hours since injury).
- Indication for closed reduction and immobilization.
- Ability to provide informed consent.
Who cannot join
- Age under 18 years or open physes on plain radiograph.
- Open or pathological distal radius fractures.
- Local infection at or near the planned injection site.
- Significant neurological disease or cognitive impairment interfering with study participation.
- Presence of osteosynthesis material in the same segment of the affected limb.
- Known allergy or contraindication to local anesthetics used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Combined Hematoma and Peripheral Nerve Block Versus Isolated Hematoma Block in the Reduction ff Distal Radius Fractures: A Prospective, Randomized, Multicenter Clinical Trial
Distal radius fractures, commonly known as wrist fractures, are among the most frequent injuries seen in emergency departments. These injuries often require a closed reduction, a procedure in which the broken bone is manipulated back into place without surgery. One of the main challenges during this procedure is providing adequate pain control.
Traditionally, many hospitals use a "hematoma block," which means injecting a local anesthetic directly into the site of the fracture. This technique is simple and generally safe, but it does not always provide enough pain relief. Some patients continue to experience significant discomfort, especially in the fingers, during the traction and manipulation required to realign the bone.
Read more
Another option is to block the median nerve at the wrist. The median nerve supplies sensation to the thumb, index, and middle fingers. When combined with a hematoma block, this technique may improve digital pain relief during fracture reduction. However, this combined approach has not been well studied in Spain, and there is limited high-quality evidence worldwide.
The purpose of this study is to compare two methods of pain control during closed reduction of displaced distal radius fractures in adults: Hematoma block alone versus Hematoma block combined with median nerve block.
We hypothesize that the combined approach will reduce pain more effectively than the hematoma block alone.
The study is designed as a prospective, multicenter, randomized clinical trial involving 112 adult patients treated at two hospitals in Madrid (Hospital Universitario 12 de Octubre and Hospital Universitario de Getafe). Eligible participants are adults aged 18 to 100 years with an acute distal radius fracture (less than 48 hours old) requiring closed reduction. Patients will be randomly assigned to one of the two treatment groups.
Pain will be assessed using a Visual Analog Scale (VAS) at three key moments: during finger traction, during the reduction itself, and at hospital discharge (90-120 minutes after casting). Other information such as age, sex, fracture side, and prior use of pain or psychiatric medication will also be collected.
By answering whether the addition of a median nerve block improves pain control, this study could help establish a new protocol for managing distal radius fractures. If effective, this approach may lead to greater comfort for patients, higher satisfaction, and better overall outcomes in emergency care.
- Being tested
- Hematoma Block, Median Nerve Block
- Keywords
- Distal Radius Fracture, Hematoma Block, Median Nerve Block, Pain Management, Closed Reduction
- Medical subject headings
- Wrist Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematoma BlockProcedure or surgery
Injection of 5-10 mL of 2% mepivacaine directly into the fracture hematoma under aseptic conditions.
Median Nerve BlockProcedure or surgery
Injection of 3-5 mL of 2% mepivacaine adjacent to the median nerve at the wrist, using anatomical landmarks.
| Study group | Role | What they receive |
|---|---|---|
| Hematoma Block | Active comparator | Participants will receive a hematoma block only. Under aseptic conditions, 5-10 mL of 2% mepivacaine will be injected directly into the fracture hematoma using a 25-27 gauge needle. No additional nerve block will be performed. This technique is currently the standard of care in the Emergency Department for closed reduction of displaced distal radius fractures. Receives: Procedure: Hematoma Block |
| Hematoma Block + Median Nerve Block | Experimental | Participants will receive both a hematoma block and a median nerve block. Median nerve block will be administered at the wrist using anatomical landmarks: 3-5 mL of 2% mepivacaine injected between palmaris longus and flexor carpi radialis. Receives: Procedure: Hematoma Block; Procedure: Median Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity During Closed Reduction
Pain will be measured using a 10-cm Visual Analog Scale (VAS, 0 = no pain, 10 = worst imaginable pain). Scores will be recorded at the wrist and fingers during traction, manipulation, and at discharge.
Measured: During fracture reduction procedure and at hospital discharge (90-120 minutes post-casting).
Secondary outcomes (2)
Demographic and Baseline Characteristics
Age, sex, fracture side (left/right), and prior use of analgesic or psychiatric medication will be collected for subgroup analyses.
Measured: At enrollment (baseline).
Incidence of Adverse Events Related to Anesthetic Techniques
Documentation of complications such as infection at injection site, hematoma, intravascular injection, systemic anesthetic toxicity (e.g., seizures, arrhythmia), or neuritis.
Measured: From intervention until hospital discharge (90-120 minutes post-casting).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Jan 2024
- Primary completion17 Jan 2025
- Study completion5 Mar 2025
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 Acute 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
- * Two-arm design with participants randomized 1:1. * One group receives hematoma block alone (control). * The other group receives hematoma block combined with median nerve block (intervention). * Randomization is stratified by study center (Hospital Universitario 12 de Octubre and Hospital Universitario de Getafe) and balanced for sex, age, fracture side, and prior medication use. * Each participant is assigned to only one study arm and followed prospectively.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Antonio Guerrero Serrano, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183904
- Sponsor's protocol ID
- 24/272
- Acronym
- BRAVE
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during the trial that underlie the primary and secondary outcomes will be shared. This includes pain scores (VAS values), demographic information (age, sex, fracture side, prior medication use), and adverse event data. No information that could directly identify a participant (e.g., names, dates of birth, hospital ID numbers) will be included. Requests should be directed to the Principal Investigator (jaguerrero14@hotmail.com)
Publications
Guerrero-Serrano JA, Santamaria-Lopez A, Garcia-Lamas L, Jimenez-Diaz V, Gonzalez-Fernandez A, Cecilia D. Does the addition of peripheral nerve blocks improve analgesia during distal radius fracture reduction? A prospective, randomized, multicenter clinical trial. Eur J Trauma Emerg Surg. 2026 Jun 15;52(1):191. doi: 10.1007/s00068-026-03245-x.
PubMed 42295389
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Combined Hematoma and Peripheral Nerve Block Versus Isolated Hematoma Block in the Reduction ff Distal Radius Fractures: A Prospective, Randomized, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT07183904
- Acronym / sponsor ID
- BRAVE / 24/272
- Keywords
- Distal Radius Fracture, Hematoma Block, Median Nerve Block, Pain Management, Closed Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 19 Sep 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.
Distal radius fractures, commonly known as wrist fractures, are among the most frequent injuries seen in emergency departments. These injuries often require a closed reduction, a procedure in which the broken bone is manipulated back into place without surgery. One of the main challenges during this procedure is providing adequate pain control.
Traditionally, many hospitals use a "hematoma block," which means injecting a local anesthetic directly into the site of the fracture. This technique is simple and generally safe, but it does not always provide enough pain relief. Some patients continue to experience significant discomfort, especially in the fingers, during the traction and manipulation required to realign the bone.
Another option is to block the median nerve at the wrist. The median nerve supplies sensation to the thumb, index, and middle fingers. When combined with a hematoma block, this technique may improve digital pain relief during fracture reduction. However, this combined approach has not been well studied in Spain, and there is limited high-quality evidence worldwide.
The purpose of this study is to compare two methods of pain control during closed reduction of displaced distal radius fractures in adults: Hematoma block alone versus Hematoma block combined with median nerve block.
We hypothesize that the combined approach will reduce pain more effectively than the hematoma block alone.
The study is designed as a prospective, multicenter, randomized clinical trial involving 112 adult patients treated at two hospitals in Madrid (Hospital Universitario 12 de Octubre and Hospital Universitario de Getafe). Eligible participants are adults aged 18 to 100 years with an acute distal radius fracture (less than 48 hours old) requiring closed reduction. Patients will be randomly assigned to one of the two treatment groups.
Pain will be assessed using a Visual Analog Scale (VAS) at three key moments: during finger traction, during the reduction itself, and at hospital discharge (90-120 minutes after casting). Other information such as age, sex, fracture side, and prior use of pain or psychiatric medication will also be collected.
By answering whether the addition of a median nerve block improves pain control, this study could help establish a new protocol for managing distal radius fractures. If effective, this approach may lead to greater comfort for patients, higher satisfaction, and better overall outcomes in emergency care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- * Two-arm design with participants randomized 1:1. * One group receives hematoma block alone (control). * The other group receives hematoma block combined with median nerve block (intervention). * Randomization is stratified by study center (Hospital Universitario 12 de Octubre and Hospital Universitario de Getafe) and balanced for sex, age, fracture side, and prior medication use. * Each participant is assigned to only one study arm and followed prospectively.
| Arm | Type | Receives |
|---|---|---|
| Hematoma Block | Active comparator | Procedure: Hematoma BlockParticipants will receive a hematoma block only. Under aseptic conditions, 5-10 mL of 2% mepivacaine will be injected directly into the fracture hematoma using a 25-27 gauge needle. No additional nerve block will be performed. This technique is currently the standard of care in the Emergency Department for closed reduction of displaced distal radius fractures. |
| Hematoma Block + Median Nerve Block | Experimental | Procedure: Hematoma Block, Procedure: Median Nerve BlockParticipants will receive both a hematoma block and a median nerve block. Median nerve block will be administered at the wrist using anatomical landmarks: 3-5 mL of 2% mepivacaine injected between palmaris longus and flexor carpi radialis. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 to 100 years.
- Diagnosis of acute displaced distal radius fracture (< 48 hours since injury).
- Indication for closed reduction and immobilization.
- Ability to provide informed consent.
Key exclusion criteria (6 listed)
- Age under 18 years or open physes on plain radiograph.
- Open or pathological distal radius fractures.
- Local infection at or near the planned injection site.
- Significant neurological disease or cognitive impairment interfering with study participation.
- Presence of osteosynthesis material in the same segment of the affected limb.
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 |
|---|---|---|
| Hematoma BlockInjection of 5-10 mL of 2% mepivacaine directly into the fracture hematoma under aseptic conditions. | Procedure or surgery | Hematoma Block, Hematoma Block + Median Nerve Block |
| Median Nerve BlockInjection of 3-5 mL of 2% mepivacaine adjacent to the median nerve at the wrist, using anatomical landmarks. | Procedure or surgery | Hematoma Block + Median Nerve Block |
Primary outcome
Pain Intensity During Closed Reduction
Time frame: During fracture reduction procedure and at hospital discharge (90-120 minutes post-casting).
Pain will be measured using a 10-cm Visual Analog Scale (VAS, 0 = no pain, 10 = worst imaginable pain). Scores will be recorded at the wrist and fingers during traction, manipulation, and at discharge.
2 secondary outcomes
Demographic and Baseline Characteristics
Time frame: At enrollment (baseline).
Incidence of Adverse Events Related to Anesthetic Techniques
Time frame: From intervention until hospital discharge (90-120 minutes post-casting).
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 19 Sep 2025.
- Derived from this study: PubMed 42295389Guerrero-Serrano JA, Santamaria-Lopez A, Garcia-Lamas L, Jimenez-Diaz V, Gonzalez-Fernandez A, Cecilia D. Does the addition of peripheral nerve blocks improve analgesia during distal radius fracture reduction? A prospective, randomized, multicenter clinical trial. Eur J Trauma Emerg Surg. 2026 Jun 15;52(1):191. doi: 10.1007/s00068-026-03245-x.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during the trial that underlie the primary and secondary outcomes will be shared. This includes pain scores (VAS values), demographic information (age, sex, fracture side, prior medication use), and adverse event data. No information that could directly identify a participant (e.g., names, dates of birth, hospital ID numbers) will be included. Requests should be directed to the Principal Investigator (jaguerrero14@hotmail.com)
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematoma Block and Median Nerve Block in people with Acute Distal Radius Fracture and Displaced Distal Radius Fracture, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
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 4 inclusion and 6 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 19 Sep 2025. 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 Spain. 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 Intensity During Closed Reduction (time frame: During fracture reduction procedure and at hospital discharge (90-120 minutes post-casting).). 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 NCT07183904, 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 19 Sep 2025.