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Completed

NCT Number: NCT07625787

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.

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

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Key information

Conditions

Distal Radius Fracture Arm Injuries Brachial Plexus Block Fractures, Bone Hematoma Block Wounds and Injuries Wrist Fractures Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, 45200, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Brachial Plexus Block

Procedure

Ultrasound-guided regional anesthesia administered by anesthesiology personnel

Hematoma Block

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Procedure-Related Complications

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Kathmandu University School of Medical Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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