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

NCT07625787 | Completed DMC

• 1 other identifier: 43/51
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Brachial Plexus Block; Hematoma Block; Distal Radius Fracture

Keywords

Brachial Plexus Block; Distal Radius Fracture; Hematoma Block

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 year

Secondary Outcomes (1)

• Procedure-Related Complications

  1 year

Study Arms (2)

Brachial Plexus Block

EXPERIMENTAL

Ultrasound-guided regional anesthesia administered by anesthesiology personnel

Procedure: Brachial Plexus Block

Hematoma Block

ACTIVE COMPARATOR

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

Procedure: Hematoma Block

Interventions

Brachial Plexus Block PROCEDURE

Ultrasound-guided regional anesthesia administered by anesthesiology personnel

Brachial Plexus Block

Hematoma Block PROCEDURE

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

Hematoma Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, 45200, Nepal

Location

Related Publications (2)

• 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.

  PMID: 35954509 RESULT

• Lari 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.

  PMID: 35982326 RESULT

MeSH Terms

Conditions

Wrist Fractures

Interventions

Brachial Plexus Block

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 4, 2026
• Study Start: January 20, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 2, 2026
• Last Updated: June 4, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

NE (1)