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

NCT06857110 | Recruiting

• 1 other identifier: 2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distal Radius Fracture

Keywords

Wrist fractures; closed fracture reduction; analgesia; Anesthesia, local; nerve block; pain measurement

Outcome Measures

Primary Outcomes (1)

• Pain during closed

  Pain experienced during the closed reduction of the distal radius fracture, measured by the numeric pain scale and reported immediately after the reduction maneuvers

  Approximately 30 minutes after the patient's arrival at the orthopedic emergency department and 15 minutes after the analgesic intervention

Secondary Outcomes (8)

• Pain reduction after the analgesic procedure

  Approximately 15 minutes after the patient's arrival at the orthopedic emergency department

• Pain reduction measured after the closed reduction

  : Approximately 30 minutes after the patient's arrival at the orthopedic emergency department and 15 minutes after the analgesic intervention

• quality of reduction measured by dorsal tilt

  Approximately 45 minutes after the patient's arrival at the orthopedic emergency department

• quality of reduction measured by radial inclination

  Approximately 45 minutes after the patient's arrival at the orthopedic emergency department

• quality of reduction measured by radial height

  Approximately 45 minutes after the patient's arrival at the orthopedic emergency department

Study Arms (2)

hematoma block

ACTIVE COMPARATOR

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, or 1 gram of oral acetaminophen in case of contraindications for the administration of Non-Steroidal Anti-inflammatory Drugs. With the patient in supine position, palpation will be conducted to locate the fracture. The skin above this area will be cleaned with 2% chlorhexidine gluconate antiseptic solution and sterile gauze. While wearing sterile gloves, the orthopedic surgeon will insert a 10 cc syringe with a 21 gauge needle and aspirate to confirm placement over the fracture hematoma. 1% Lidocaine without epinephrine will be infiltrated (dose of 2mg/kg). A 10-minute waiting period will be observed before performing closed reduction maneuvers.

Procedure: hematoma block; Drug: 5 mg of intramuscular diclofenac

Procedure/surgery

EXPERIMENTAL

The orthopedic surgeon will perform an ultrasound-guided supracondylar block of the radial nerve prior to closed reduction. Intramuscular diclofenac (75 mg) or oral acetaminophen (1 g) will be administered if NSAIDs are contraindicated. With the patient seated, the lateral epicondyle of the humerus will be identified through palpation and ultrasound. After antisepsis with 2% chlorhexidine gluconate, a non-cutting needle (Stimuplex 50 mm) will be inserted approximately 3 cm proximal to the lateral epicondyle, and 1% lidocaine (2 mg/kg) without epinephrine will be administered. A 10-minute waiting period will be observed before performing the closed reduction maneuvers.

Procedure: ultrasound-guided supracondylar block of the radial nerve

Interventions

ultrasound-guided supracondylar block of the radial nerve PROCEDURE

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

Procedure/surgery

hematoma block PROCEDURE

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.

hematoma block

5 mg of intramuscular diclofenac DRUG

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

hematoma block

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead
• Pontificia Universidad Javeriana: collaborator

Study Sites (1)

Hospital Universitario San Ignacio

Bogotá, Bogota D.C., Colombia

RECRUITING

MeSH Terms

Conditions

Wrist Fractures; Agnosia

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis A García González, Orthopedic Surgeon and Traumat

  Hospital Universitario San Ignacio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking Since this study involves two non-invasive, clearly distinguishable interventions, it is not possible to blind the patient to the assigned treatment or to blind the healthcare professionals administering the intervention or recording the outcome. However, data analysis will be conducted with blinding of the administered intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)