About this trial
The goal of this observational clinical trial is to assess the impact of Regional Anesthesia (RA) techniques with the strongest anatomical and scientific support in controlling acute post-operative pain in pelvic/acetabular fractures, as well as their potential role in reducing complications related to excessive intra- and postoperative opioid use.
The main questions it aims to answer are:
Does RA lower opioid use in the first 24 hours after pelvic/acetabular fractures surgery? Does RA lower pain scores in the first 48 hours after surgery, incidence of complications and occurrence of persistent post-surgical pain?
During the hours and days following surgery, the research team will evaluate and assess the intensity of any postoperative pain at predefined time points; quantify the use of pain medications and any related complications; and measure the possible onset of chronic pain and the timeline of functional recovery (through scheduled clinical follow-up at 30, 60, and 90 days).
Participants will:
at the time of surgery, and only in the presence of trained and certified anesthesiologists, patients will receive regional anesthesia techniques in addition to the standard multimodal analgesic treatment. In the absence of certified anesthesiologists, patients will be treated exclusively with systemic multimodal analgesia according to the standard protocol.
All the procedures are part of the current clinical practice and no experimental techniques or medications are involved.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years and ability to provide informed consent
Patients with pelvic/acetabular fractures requiring surgery
Disqualifiers
Age < 18 years
Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)
Trial population
Patients with pelvic/acetabular fractures presenting to the Emergency and Trauma Department, either as primary transport or secondary referral, who require surgery (percutaneous or via open reduction/internal fixation).
Trial design
Case-control
Prospective
Treatments tested in this trial
Regional Anesthesia
Procedure/Surgery* Supra-inguinal fascia iliaca block (SIFI) * Lumbar erector spinae plane block (ESP) * Transmuscular quadratus lumborum block (QLB) All blocks will be performed by experienced anesthesiologists under ultrasound guidance, using long-acting anesthetics (ropivacaine) at fixed concentrations and doses within weight-based safety limits.
Multimodal analgesia
DrugAll enrolled subjects will be treated according to the standard analgesic protocol for pelvic fractures, in accordance with available literature and institutional guidelines. Specifically, the protocols include the use of multimodal analgesia techniques in line with current clinical practice, including paracetamol, non-steroidal anti-inflammatory drugs, opioids.
Treatment groups
Trial outcomes
Primary outcomes
Opioid consumption
Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours.
Secondary outcomes
Pain Scores
Area under the curve (AUC) of acute pain scores (measured via Numeric Rating Scale - NRS)
Persistent post-surgical pain
Incidence of chronic post-operative/post-traumatic pain assessed via Numeric rating scale (NRS) through telephone follow-up.
Opioids Side Effects
Incidence of acute side effects related to opioid use (excessive sedation, nausea/vomiting, respiratory depression, pruritus, urinary retention, constipation).
RA side effects
Incidence of complications related to nerve blocks (block failure, nerve damage, hematoma, systemic local anesthetic toxicity).
Sponsors and contacts
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