Distal Radius FractureNCT07625787
Efficacy and Safety of Hematoma Block Versus Brachial Plexus Block for Closed Reduction of Extra-Articular Distal Radius Fracture: A Prospective Study
A study testing Brachial Plexus Block and Hematoma Block in people with Distal Radius Fracture and Brachial Plexus Block, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial summary
Distal radius fractures are one of the most common types of fractures, affecting mostly youngsters and the elderly. Safety, ease of use, affordability, and effectiveness all play a role in analgesia during reduction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Brachial Plexus Block, Hematoma Block
- What is being tested?
- Brachial Plexus Block and Hematoma Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNepal
- Study dates
- 20 Jan 2024to 2 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients in the age range of skeletally mature (18 years and above)
- Displaced distal radius fracture, requiring manipulation
- Only extra-articular fractures.
Who cannot join
- Open fractures (Gustilo Anderson open fracture Type I, II and III), intra-articular fractures, and comminuted fractures.
- Undisplaced distal radial fractures which do not require manipulation.
- Patients who have a history of an adverse reaction to local anesthetics.
- Polytrauma, multiple injuries
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Dhulikhel Hospital, Kathmandu University Hospital
Dhulikhel, Bagmati, 45200
About this study
Official title: EFFICACY AND SAFETY OF HEMATOMA BLOCK VERSUS BRACHIAL PLEXUS BLOCK FOR CLOSED REDUCTION OF EXTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PROSPECTIVE STUDY
Distal radius fractures are one of the most common types of fractures, affecting mostly youngsters and the elderly. Safety, ease of use, affordability, and effectiveness all play a role in analgesia during reduction. This study's goal is to assess how well the Hematoma Block (HB) reduces distal forearm fractures in a developing nation like Nepal. At a tertiary care hospital, a randomized comparative study is used. The individuals with distal forearm fractures that have been radiologically confirmed are enrolled after taking informed consent. When reducing distal forearm fractures, the patients are divided into two groups: Brachial Plexus Block (BPB group) and Hematoma Block group. We note the level of pain before, during, and after reduction using the Visual Analogue Scale (VAS) in both groups. The patient's radiological correction is assessed by Modified Sarmiento Criteria with an immediate post reduction radiograph.
Comparing Hematoma Block and Brachial Plexus Block, we can choose a definitive easy method for reduction that is easy, safe and less time consuming. Hence, the study will provide a guide for commonly occurring distal radius fracture.
Read more
Hypotheses of the Study:
Null hypothesis (Ho): There is no difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.
Ho: Safety, efficacy and quality of reduction with Hematoma block = Brachial plexus block
Alternate hypothesis (H1): There is a difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.
H1: Safety, efficacy and quality of reduction with Hematoma block ≠ Brachial plexus block
- Being tested
- Brachial Plexus Block, Hematoma Block
- Keywords
- Brachial Plexus Block, Distal Radius 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.
Brachial Plexus BlockProcedure or surgery
Ultrasound-guided regional anesthesia administered by anesthesiology personnel
Hematoma BlockProcedure or surgery
Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident.
| Study group | Role | What they receive |
|---|---|---|
| Brachial Plexus Block | Experimental | Ultrasound-guided regional anesthesia administered by anesthesiology personnel Receives: Procedure: Brachial Plexus Block |
| Hematoma Block | Active comparator | Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident. Receives: Procedure: Hematoma Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity Assessed by Visual Analogue Scale (VAS)
Pain severity during fracture reduction will be assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. Pain scores will be recorded prior to, during, and immediately following fracture reduction. Higher scores indicate worse pain severity.
Measured: 1 year
Quality of Fracture Reduction Assessed by Plain Radiographic Parameters
Quality of reduction following fracture manipulation will be assessed using plain radiographs in posteroanterior (PA) and lateral views. Radiographic parameters include ulnar variance (mm), radial length (mm), radial tilt (degrees), and dorsal/palmar tilt (degrees). Measurements will be compared between hematoma block and brachial plexus block groups.
Measured: 1 year
Secondary outcomes (1)
Procedure-Related Complications
Complications related to fracture reduction or anesthesia technique will be recorded during hospital stay and follow-up. Complications may include neurovascular injury, compartment syndrome, local anesthetic-related adverse events, infection, or failure of reduction. Outcome will be reported as number and percentage of participants experiencing complications.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start20 Jan 2024
- Primary completion1 Apr 2026
- Study completion2 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Shrestha, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625787
- Sponsor's protocol ID
- 43/51
- Status last verified
- Jan 2024
- First submitted
- 24 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Nho JH, Jang BW, An CY, Yoo JH, Song S, Cho HB, Kim SH, Kim SI, Jung KJ, Kim B. General versus Brachial Plexus Block Anesthesia in Pain Management after Internal Fixation in Patients with Distal Radius Fracture: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jul 27;19(15):9155. doi: 10.3390/ijerph19159155.
PubMed 35954509Lari A, Jarragh A, Alherz M, Nouri A, Behbehani M, Alnusif N. Circumferential periosteal block versus hematoma block for the reduction of distal radius and ulna fractures: a randomized controlled trial. Eur J Trauma Emerg Surg. 2023 Feb;49(1):107-113. doi: 10.1007/s00068-022-02078-8. Epub 2022 Aug 18.
PubMed 35982326
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY AND SAFETY OF HEMATOMA BLOCK VERSUS BRACHIAL PLEXUS BLOCK FOR CLOSED REDUCTION OF EXTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT07625787
- Acronym / sponsor ID
- 43/51
- Keywords
- Brachial Plexus Block, Distal Radius Fracture, Hematoma Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 2 Apr 2026 (actual)
- First posted
- 4 Jun 2026 (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 are one of the most common types of fractures, affecting mostly youngsters and the elderly. Safety, ease of use, affordability, and effectiveness all play a role in analgesia during reduction. This study's goal is to assess how well the Hematoma Block (HB) reduces distal forearm fractures in a developing nation like Nepal. At a tertiary care hospital, a randomized comparative study is used. The individuals with distal forearm fractures that have been radiologically confirmed are enrolled after taking informed consent. When reducing distal forearm fractures, the patients are divided into two groups: Brachial Plexus Block (BPB group) and Hematoma Block group. We note the level of pain before, during, and after reduction using the Visual Analogue Scale (VAS) in both groups. The patient's radiological correction is assessed by Modified Sarmiento Criteria with an immediate post reduction radiograph.
Comparing Hematoma Block and Brachial Plexus Block, we can choose a definitive easy method for reduction that is easy, safe and less time consuming. Hence, the study will provide a guide for commonly occurring distal radius fracture.
Hypotheses of the Study:
Null hypothesis (Ho): There is no difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.
Ho: Safety, efficacy and quality of reduction with Hematoma block = Brachial plexus block
Alternate hypothesis (H1): There is a difference between feasibility, safety and quality of reduction in the two groups of anesthesia techniques.
H1: Safety, efficacy and quality of reduction with Hematoma block ≠ Brachial plexus block
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brachial Plexus Block | Experimental | Procedure: Brachial Plexus BlockUltrasound-guided regional anesthesia administered by anesthesiology personnel |
| Hematoma Block | Active comparator | Procedure: Hematoma BlockLocal anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female patients in the age range of skeletally mature (18 years and above)
- Displaced distal radius fracture, requiring manipulation
- Only extra-articular fractures.
Key exclusion criteria (4 listed)
- Open fractures (Gustilo Anderson open fracture Type I, II and III), intra-articular fractures, and comminuted fractures.
- Undisplaced distal radial fractures which do not require manipulation.
- Patients who have a history of an adverse reaction to local anesthetics.
- Polytrauma, multiple injuries
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 |
|---|---|---|
| Brachial Plexus BlockUltrasound-guided regional anesthesia administered by anesthesiology personnel | Procedure or surgery | Brachial Plexus Block |
| Hematoma BlockLocal anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident. | Procedure or surgery | Hematoma Block |
Primary outcome
Pain Severity Assessed by Visual Analogue Scale (VAS)
Time frame: 1 year
Pain severity during fracture reduction will be assessed using the Visual Analogue Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. Pain scores will be recorded prior to, during, and immediately following fracture reduction. Higher scores indicate worse pain severity.
Quality of Fracture Reduction Assessed by Plain Radiographic Parameters
Time frame: 1 year
Quality of reduction following fracture manipulation will be assessed using plain radiographs in posteroanterior (PA) and lateral views. Radiographic parameters include ulnar variance (mm), radial length (mm), radial tilt (degrees), and dorsal/palmar tilt (degrees). Measurements will be compared between hematoma block and brachial plexus block groups.
1 secondary outcome
Procedure-Related Complications
Time frame: 1 year
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 4 Jun 2026.
- Results publication: PubMed 35954509Nho JH, Jang BW, An CY, Yoo JH, Song S, Cho HB, Kim SH, Kim SI, Jung KJ, Kim B. General versus Brachial Plexus Block Anesthesia in Pain Management after Internal Fixation in Patients with Distal Radius Fracture: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Jul 27;19(15):9155. doi: 10.3390/ijerph19159155.
- Results publication: PubMed 35982326Lari A, Jarragh A, Alherz M, Nouri A, Behbehani M, Alnusif N. Circumferential periosteal block versus hematoma block for the reduction of distal radius and ulna fractures: a randomized controlled trial. Eur J Trauma Emerg Surg. 2023 Feb;49(1):107-113. doi: 10.1007/s00068-022-02078-8. Epub 2022 Aug 18.
- Individual participant dataSharing planned: Yes
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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 Brachial Plexus Block and Hematoma Block in people with Distal Radius Fracture and Brachial Plexus Block, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
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 4 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 4 Jun 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 Nepal. 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 Severity Assessed by Visual Analogue Scale (VAS) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT07625787, which also lists 2 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 4 Jun 2026.