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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA group | Patients treated with RA techniques in association to multimodal analgesia |
| |
| Multimodal Analgesia Group | Patients treated with multimodal analgesia alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anesthesia | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours. | Up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Area under the curve (AUC) of acute pain scores (measured via Numeric Rating Scale - NRS) | post-operatively at 6, 12, 24 and 48 hours following surgery |
| Persistent post-surgical pain |
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Inclusion Criteria:
Exclusion Criteria
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marco Ulla, MD | Contact | +39-3397548673 | marco.ulla@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy Hospital | Recruiting | Turin | 10126 | Italy |
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| Multimodal analgesia | Drug | 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. |
|
Incidence of chronic post-operative/post-traumatic pain assessed via Numeric rating scale (NRS) through telephone follow-up.
| 30, 60, 90-days after surgery |
| Opioids Side Effects | Incidence of acute side effects related to opioid use (excessive sedation, nausea/vomiting, respiratory depression, pruritus, urinary retention, constipation). | Up to 48 hours after surgery |
| RA side effects | Incidence of complications related to nerve blocks (block failure, nerve damage, hematoma, systemic local anesthetic toxicity). | Up to 48 hours after surgery |
| Hospital length of stay | Days of admission in the hospital where surgery is provided | From surgery up to the first follow up at 30 days |
| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| D000377 | Agnosia |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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