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

NCT07072286 | Recruiting

• 1 other identifier: 00179/2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

regional anethesia; pain management; pelvic fractures; acetabular fractures; surgery

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours.

  Up to 24 hours after surgery

Secondary Outcomes (5)

• Pain Scores

  post-operatively at 6, 12, 24 and 48 hours following surgery

• Persistent post-surgical pain

  30, 60, 90-days after surgery

• Opioids Side Effects

  Up to 48 hours after surgery

• RA side effects

  Up to 48 hours after surgery

• Hospital length of stay

  From surgery up to the first follow up at 30 days

Study Arms (2)

RA group

Patients treated with RA techniques in association to multimodal analgesia

Procedure: Regional Anesthesia; Drug: Multimodal analgesia

Multimodal Analgesia Group

Patients treated with multimodal analgesia alone

Drug: Multimodal analgesia

Interventions

Regional Anesthesia 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.

RA group

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.

Multimodal Analgesia Group; RA group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• Age ≥ 18 years and ability to provide informed consent
• Patients with pelvic/acetabular fractures requiring surgery

You may not qualify if:

• Age \< 18 years
• Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

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

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Accidental Injuries; Agnosia; Hip Fractures

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Marco Ulla, MD

CONTACT

+39-3397548673; marco.ulla@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): September 25, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

IT (1)