Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
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
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
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
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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