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.