RecruitingNot ApplicableNCT06857110

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

"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"


Sponsor

Hospital Universitario San Ignacio

Enrollment

50 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Non-surgical treatment with closed reduction and immobilization using a splint or cast is the preferred approach for stable distal radius fractures, particularly in elderly patients. It is also the initial intervention for displaced fractures with a surgical indication before the procedure, aiming to reduce edema, manage pain, and prevent associated complications. However, the maneuvers required for bone reduction can cause significant pain, and there is still insufficient evidence to favor one anesthetic method over another. In recent years, there has been a trend toward utilizing local methods, such as hematoma block or ultrasound-guided supracondylar block of the radial nerve, due to their lower incidence of complications. Nonetheless, there are currently no studies comparing the efficacy of these two analgesic approaches. This study aims to compare the analgesic effect of ultrasound-guided supracondylar block with that obtained through hematoma block in patients with distal radius fracture during closed reduction, using the Numeric Rating Scale. Additionally, it aims to compare the quality of the reduction through radiographic measures and assess the frequency of adverse events after the two interventions.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patients over 18 years old with skeletal maturity evidenced in the initial radiographs.
  • Patients with a radiological diagnosis of distal radius fracture
  • Patients whose clinical condition is considered acute (duration of symptoms less than one week).
  • Patients who have an indication for closed reduction as a definitive or initial management of their distal radius fracture
  • Patients treated at San Ignacio University Hospital in Bogotá, Colombia

Exclusion Criteria9

  • Patients with bilateral distal radius fractures
  • Patients with open distal radius fractures.
  • Patients with another fracture in the same limb
  • Patients in a state of intoxication or under the influence of psychoactive substances.
  • Patients with hemodynamic instability that prevents prioritizing closed reduction as management.
  • Patients with a known allergy to local anesthetics
  • Patients on full-dose anticoagulant therapy.
  • Patients who refuse to participate in the study
  • Patients with cognitive, visual, or auditory impairments that prevent the proper completion of questionnaires

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Interventions

PROCEDUREultrasound-guided supracondylar block of the radial nerve

75 mg of intramuscular diclofenac will be administered, or 1 gram of oral acetaminophen in case of contraindications for the administration of Non-Steroidal Anti-inflammatory Drugs

PROCEDUREhematoma block

The orthopedic surgeon will perform a hematoma block before closed reduction. Intramuscular diclofenac (75 mg) or oral acetaminophen (1 g) will be administered if NSAIDs are contraindicated. With the patient in a supine position, the fracture site will be identified through palpation. After antisepsis with 2% chlorhexidine gluconate, a 10 cc syringe with a 21-gauge needle will be inserted to aspirate and confirm placement over the fracture hematoma. Then, 1% lidocaine (2 mg/kg) without epinephrine will be infiltrated. A 10-minute waiting period will be observed before performing closed reduction maneuvers.

DRUG5 mg of intramuscular diclofenac

the orthopedic surgeon on duty will perform the hematoma block prior to closed reduction in the procedure room as follows: 75 mg of intramuscular diclofenac will be administered


Locations(1)

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

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NCT06857110


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