Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06857110

Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures: a Randomized Controlled Clinical Trial

Led by Hospital Universitario San Ignacio · Updated on 2025-03-17

50

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

H

Hospital Universitario San Ignacio

Lead Sponsor

P

Pontificia Universidad Javeriana

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two different local anesthetic methods for pain control during closed reduction of distal radius fractures, focusing on elderly and adult patients. The study compares ultrasound-guided supracondylar block of the radial nerve with hematoma block to determine which provides better pain relief during the procedure. The trial also assesses the quality of bone reduction using radiographic measurements and monitors adverse events for safety. Participants receive either a hematoma block or an ultrasound-guided supracondylar radial nerve block before the closed reduction maneuver. Both groups receive pain medication with diclofenac or acetaminophen if NSAIDs are contraindicated. After a 10-minute wait following the analgesic administration, the closed reduction is performed manually, and the wrist is immobilized with a cast or splint. Radiographs are taken before and after reduction to measure bone alignment. During the study, demographic and clinical data are collected, including pain levels before and after analgesia and reduction, using a numeric pain scale. Researchers record radiographic outcomes such as radial height and dorsal tilt, as well as any complications or adverse effects occurring up to three hours post-intervention. The trial includes blinded data analysis and an interim evaluation to monitor safety and effectiveness, with results intended for publication.

CONDITIONS

Brief Title

"Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures"

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years old with skeletal maturity shown on initial X-rays
  • Radiological diagnosis of distal radius fracture
  • Acute clinical condition with symptoms less than one week old
  • Indication for closed reduction as definitive or initial management
  • Patients treated at San Ignacio University Hospital in Bogot�e1, Colombia
Not Eligible

You will not qualify if you...

  • Patients with fractures on both wrists
  • Patients with open distal radius fractures
  • Patients with another fracture in the same limb
  • Patients intoxicated or under psychoactive substances
  • Patients with hemodynamic instability preventing closed reduction
  • Patients allergic to local anesthetics
  • Patients on full-dose anticoagulant therapy
  • Patients who refuse to participate
  • Patients with cognitive, visual, or hearing impairments preventing questionnaire completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment and informed consent

Treatment

Duration - Single day intervention with assessments up to 3 hours post-intervention

Participants receive either an ultrasound-guided supracondylar radial nerve block or a hematoma block as analgesic management prior to closed reduction of distal radius fractures. Pain is assessed before, after the analgesic procedure, during closed reduction, and post-reduction radiographs are taken.

1 visit (in-person) including intervention and assessments

Follow-up

Duration - Up to 3 hours after treatment

Participants are observed for any complications or adverse effects occurring during the procedure and up to 3 hours after the intervention.

Monitoring during the same visit after treatment

Trial Site Locations

Total: 1 location

1

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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