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NCT Number: NCT07072286

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Turin, 10126, Italy

Location status: Recruiting

Location contact

Marco Ulla, MD

CONTACT

[email protected]

+39-3397548673

Marco Ulla, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Opioid consumption

    Time frame: Up to 24 hours after surgery

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

Secondary outcomes

  1. Pain Scores

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

    Area under the curve (AUC) of acute pain scores (measured via Numeric Rating Scale - NRS)

  2. Persistent post-surgical pain

    Time frame: 30, 60, 90-days after surgery

    Incidence of chronic post-operative/post-traumatic pain assessed via Numeric rating scale (NRS) through telephone follow-up.

  3. Opioids Side Effects

    Time frame: Up to 48 hours after surgery

    Incidence of acute side effects related to opioid use (excessive sedation, nausea/vomiting, respiratory depression, pruritus, urinary retention, constipation).

  4. RA side effects

    Time frame: Up to 48 hours after surgery

    Incidence of complications related to nerve blocks (block failure, nerve damage, hematoma, systemic local anesthetic toxicity).

  5. Hospital length of stay

    Time frame: From surgery up to the first follow up at 30 days

    Days of admission in the hospital where surgery is provided

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Ulla, MD

CONTACT

[email protected]

+39-3397548673

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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."

Acronym: RELIEVED

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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