Clinical trial NCT06857110: "Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures"
Official title: "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"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Distal Radius Fracture
Keywords: Wrist fractures
closed fracture reduction
analgesia
Anesthesia, local
nerve block
pain measurement
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Javeriana
First posted: 2025-03-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Approval has been obtained from the ethics committee. A process of informed consent will be conducted with all participants, ensuring confidentiality and data protection. Once the informed consent is signed, either an orthopedic surgeon or resident will gather demographic data such as age, sex, height, weight and analgesics taken during the same day of the intervention. Additionally, the type of fracture according to the AO classification and the perceived pain before the intervention will be registered in REDCap

Subsequently, this healthcare personnel in the emergency room will contact a member of the research team, who will conduct randomization of the intervention though REDcap and determine which analgesic approach should be offered to the participant.

Training and education will be provided to orthopedic surgeons working in the emergency room to standardize the local analgesic interventions, following the recommendations outlined in the study protocol.

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.

After a 10-minute waiting period following the analgesic procedure, the participants' pain will be reassessed using the numeric pain scale. After this, all patients will undergo closed reduction through manual reduction maneuvers. This involves the patient being placed in supine position, while two doctors perform traction along the axis of the arm and countertraction at the elbow for 2-5 minutes to impact the fracture. Subsequently, wrist extension, flexion, and ulnar deviation of at least 15° will be performed, with manual pressure applied on the dorsal aspect of the radius if necessary. Finally, the patient will be immobilized with a brachy metacarpal closed cast or splint, and post-reduction radiographs will be taken. Patients will be asked to rate the pain experienced during this reduction.

Radiographs before and after the reduction will also be taken, following a standardized protocol. The posteroanterior projection will be performed with the wrist and elbow at shoulder height, aligning the joints in the transverse plane. The palm of the hand will be in contact with the cassette, as in this position, the radius and ulna are parallel. The lateral projection will be taken with the shoulder, elbow, and wrist aligned in the sagittal plane, positioning the edge of the distal ulna on the cassette. In the posteroanterior projection, the radial height, ulnar variance, and radial inclination will be measured, while the dorsal/volar tilt will be measured on the lateral projection.

Finally, all complications during the procedure or adverse effects occurring 3 hours after the intervention will be registered.

An intention-to-treat analysis will be conducted. Descriptive statistics will be generated using R studio for the demographic variables. The 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 and during the reduction will be registered and compared using an exact Fischer test.

Additionally, the proportion of patients with an adequate reduction will be compared between the two interventions for each of the radiographic measures, categorized as within or outside the ideal range. Finally, the proportion of complications and adverse effects for each intervention will be compared using an exact Fischer test.

An interim analysis will be conducted when half of the sample has been recruited to evaluate the efficacy and safety of the interventions in a blinded manner. The study will conclude if clear benefits are found with an intervention or if statistically significant harm is evidenced. An O'Brien-Fleming method will be employed to adjust the significance level for this interim analysis, aiming to control Type I error.

The results will be reported collectively for publication in a peer-reviewed journal.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* • 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

Primary outcomes:
measure: Pain during closed
timeFrame: Approximately 30 minutes after the patient's arrival at the orthopedic emergency department and 15 minutes after the analgesic intervention
Secondary outcomes:
measure: Pain reduction after the analgesic procedure
timeFrame: Approximately 15 minutes after the patient's arrival at the orthopedic emergency department
measure: Pain reduction measured after the closed reduction
timeFrame: : Approximately 30 minutes after the patient's arrival at the orthopedic emergency department and 15 minutes after the analgesic intervention
measure: quality of reduction measured by dorsal tilt
timeFrame: Approximately 45 minutes after the patient's arrival at the orthopedic emergency department
measure: quality of reduction measured by radial inclination
timeFrame: Approximately 45 minutes after the patient's arrival at the orthopedic emergency department
measure: quality of reduction measured by radial height
timeFrame: Approximately 45 minutes after the patient's arrival at the orthopedic emergency department
measure: quality of reduction measured by ulnar variance
timeFrame: Approximately 45 minutes after the patient's arrival at the orthopedic emergency department
measure: Complications
timeFrame: Approximately 30 minutes after the patient's arrival at the orthopedic emergency department
measure: Adverse events
timeFrame: during the first three hours after the intervention
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
state: Bogotá
Study officials:
affiliation: Hospital Universitario San Ignacio
name: Luis A García González, Orthopedic Surgeon and Traumat
role: PRINCIPAL_INVESTIGATOR
References: