Acetabular Fractures, Acetabular Surgery, Pelvic Bone Injury, Pelvis Injury, Trauma Injury
Conditions
Keywords
regional anethesia, pain management, pelvic fractures, acetabular fractures, surgery
Brief summary
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.
Interventions
PROCEDURERegional Anesthesia
* 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.
DRUGMultimodal analgesia
All 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.
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and ability to provide informed consent * Patients with pelvic/acetabular fractures requiring surgery
Exclusion criteria
* Age \< 18 years * Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | Up to 24 hours after surgery | Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | post-operatively at 6, 12, 24 and 48 hours following surgery | Area under the curve (AUC) of acute pain scores (measured via Numeric Rating Scale - NRS) |
| Persistent post-surgical pain | 30, 60, 90-days after surgery | Incidence of chronic post-operative/post-traumatic pain assessed via Numeric rating scale (NRS) through telephone follow-up. |
| Opioids Side Effects | Up to 48 hours after surgery | Incidence of acute side effects related to opioid use (excessive sedation, nausea/vomiting, respiratory depression, pruritus, urinary retention, constipation). |
| RA side effects | Up to 48 hours after surgery | Incidence of complications related to nerve blocks (block failure, nerve damage, hematoma, systemic local anesthetic toxicity). |
| Hospital length of stay | From surgery up to the first follow up at 30 days | Days of admission in the hospital where surgery is provided |
Countries
Italy
Contacts
CONTACTMarco Ulla, MD
Outcome results
None listed