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Efficacy and Safety of Hematoma Block Versus Brachial Plexus Block for Closed Reduction of Extra-Articular Distal Radius Fracture: A Prospective Study

EFFICACY AND SAFETY OF HEMATOMA BLOCK VERSUS BRACHIAL PLEXUS BLOCK FOR CLOSED REDUCTION OF EXTRA-ARTICULAR DISTAL RADIUS FRACTURE: A PROSPECTIVE STUDY

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07625787
Enrollment
90
Registered
2026-06-04
Start date
2024-01-20
Completion date
2026-04-02
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brachial Plexus Block, Distal Radius Fracture, Hematoma Block

Keywords

Brachial Plexus Block, Distal Radius Fracture, Hematoma Block

Brief 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. 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

Interventions

PROCEDUREBrachial Plexus Block

Ultrasound-guided regional anesthesia administered by anesthesiology personnel

Local anesthetic infiltration into the fracture hematoma by an orthopedic surgeon/resident.

Sponsors

Kathmandu University School of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adult male or female patients in the age range of skeletally mature (18 years and above) 2. Displaced distal radius fracture, requiring manipulation 3. Only extra-articular fractures.

Exclusion criteria

1. Open fractures (Gustilo Anderson open fracture Type I, II and III), intra-articular fractures, and comminuted fractures. 2. Undisplaced distal radial fractures which do not require manipulation. 3. Patients who have a history of an adverse reaction to local anesthetics. 4. Polytrauma, multiple injuries

Design outcomes

Primary

MeasureTime frameDescription
Pain Severity Assessed by Visual Analogue Scale (VAS)1 yearPain 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 Parameters1 yearQuality 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.

Secondary

MeasureTime frameDescription
Procedure-Related Complications1 yearComplications 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.

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026