RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regional Anesthesia, Multimodal analgesia.
- Who it may be relevant to
- Registry conditions: Pelvic Bone Injury, Pelvis Injury, Acetabular Fractures, Acetabular Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study. Pain Management in Surgical and Conservative Settings."
Overview
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
- Procedure Regional 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. - Drug Multimodal 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.
Primary outcome measures
- Opioid consumption [Time frame: Up to 24 hours after surgery]
Secondary outcome measures (5)
- Pain Scores [Time frame: post-operatively at 6, 12, 24 and 48 hours following surgery]
- Persistent post-surgical pain [Time frame: 30, 60, 90-days after surgery]
- Opioids Side Effects [Time frame: Up to 48 hours after surgery]
- RA side effects [Time frame: Up to 48 hours after surgery]
- Hospital length of stay [Time frame: From surgery up to the first follow up at 30 days]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy — Turin
Identifiers
NCT: NCT07072286 · 00179/2024