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

NCT ID: NCT07072286

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2026-09-25

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

RA group

Patients treated with RA techniques in association to multimodal analgesia

Regional Anesthesia

Intervention Type: PROCEDURE

• 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

Intervention Type: 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.

Multimodal Analgesia Group

Patients treated with multimodal analgesia alone

Multimodal analgesia

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy Hospital

Turin, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Marco Ulla, MD

Role: CONTACT

marco.ulla@gmail.com

+39-3397548673

Facility Contacts

Marco Ulla, MD

Role: primary

marco.ulla@gmail.com

+39-3397548673

Other Identifiers

00179/2024

Identifier Type: -

Identifier Source: org_study_id