RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in Pelvic Fractures: A Prospective, Monocentric, Pilot Cohort Study.

A.O.U. Città della Salute e della Scienza

Status: Enrolling

Conditions: Acetabular Fractures; Trauma Injury; Acetabular Surgery; Pelvis Injury; Pelvic Bone Injury

Treatments: Procedure: Regional Anesthesia; Drug: Multimodal analgesia

Study type: Observational

Funder types: Other

Identifiers

NCT07072286

00179/2024

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

200 participants in 2 patient groups

RA group

Description:

Patients treated with RA techniques in association to multimodal analgesia

Treatment:

Drug: Multimodal analgesia

Procedure: Regional Anesthesia

Multimodal Analgesia Group

Description:

Patients treated with multimodal analgesia alone

Treatment:

Drug: Multimodal analgesia