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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario San Ignacio

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound-guided supracondylar block of the radial nerve

    Procedure/Surgery

    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

  • hematoma block

    Procedure/Surgery

    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.

  • 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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: hematoma blockActive comparator 2 interventions
Group B: Procedure/surgeryExperimental treatment 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Pain reduction after the analgesic procedure

Proportion of patients experiencing a reduction greater than two points (which corresponds to the minimal clinically important difference) between baseline pain and pain experienced after the analgesic procedure. the escale use is Visual Analogue Scale. It consists of a horizontal line of 10 cm (or 100 mm), where one end represents "no pain" (0) and the other end "the worst pain imaginable" (10 or 100, depending on the scale used). The higher the scale value, the worse the patient's health condition and the greater the pain.

Time frame
Approximately 15 minutes after the patient's arrival at the orthopedic emergency department
2

Pain reduction measured after the closed reduction

proportion of patients experiencing a reduction greater than two points (which corresponds to the minimal clinically important difference) between baseline pain and during the closed reduction of the fracture

Time frame
: Approximately 30 minutes after the patient's arrival at the orthopedic emergency department and 15 minutes after the analgesic intervention
3

quality of reduction measured by dorsal tilt

in a lateral x-ray wrist projection, dorsal tilt is the angle formed between a line drawn between the most distal points of the dorsal and palmar lips of the distal radius and a line perpendicular to the axis of the radius. This measurement is important as its value is directly associated with the functional position of the wrist and its extension capacity. Its alteration is related to a dorsal displacement of the contact surface between the radius, scaphoid, and lunate, causing an abnormal increase in joint pressure and dysfunction of radiocarpal stability. It has been established that a volar tilt of less than 3° after reduction is inadequate.

Time frame
Approximately 45 minutes after the patient's arrival at the orthopedic emergency department
4

quality of reduction measured by radial inclination

In a posteroanterior x-ray wrist projection, radial inclination is the angle between a line drawn from the styloid tip to the lunate facet of the radius and a line perpendicular to the axial axis of the radius. Its normal value i son average 21 to 25 degrees.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Universitario San Ignacio

Lead sponsor

Pontificia Universidad Javeriana

Collaborator