ClinicalTrials.gg
RecruitingNCT07072286RELIEVEDUpdated Sep 2, 2026

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

An observational study in Pelvic Bone Injury, Pelvis Injury and Acetabular Fractures, sponsored by A.O.U. Città della Salute e della Scienza. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by A.O.U. Città della Salute e della Scienza · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
177
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • regional anethesia
  • pain management
  • pelvic fractures
  • acetabular fractures
  • surgery
03

In context

Accidental Injuries

128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.

This study's planned enrollment of 177 is close to the median of 170 across 59 observational studies indexed under Accidental Injuries.

Browse Accidental Injuries studies →

Lead sponsor

A.O.U. Città della Salute e della Scienza is the lead sponsor of 65 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • Age \< 18 years
  • Absolute to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
177 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureRegional 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.

  • 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.

06

What researchers measure

Primary outcomes

  1. Opioid consumption

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

    Time frame: Up to 24 hours after surgery

Secondary outcomes

  1. Pain Scores

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

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

  2. Persistent post-surgical pain

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

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

  3. Opioids Side Effects

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

    Time frame: Up to 48 hours after surgery

  4. RA side effects

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

    Time frame: Up to 48 hours after surgery

  5. Hospital length of stay

    Days of admission in the hospital where surgery is provided

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

07

Study locations

1 of 1 sites recruiting
  • Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy Hospital
    Turin, 10126, Italy
    Recruiting
    • Marco Ulla, MD · Contactmarco.ulla@gmail.com · +39-3397548673
    • Marco Ulla, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Oct 2026, 27 months after the start.

Of 33 non-industry observational studies under Accidental Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's planned 27 months is above that.

Counting every sponsor, half of 39 studies reached it within 31 months; a quarter within 12 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2025
First posted
Jul 18, 2025
StartActual
Jul 25, 2024
Primary completionEst.
Oct 25, 2026
CompletionEst.
Jan 25, 2027
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07072286
Lead sponsor
A.O.U. Città della Salute e della Scienza
Responsible party
Sponsor
First posted
Jul 18, 2025
Start date
Jul 25, 2024
Primary completion
Oct 25, 2026 (estimated)
Completion
Jan 25, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Marco Ulla, MD
Contact
marco.ulla@gmail.com
+39-3397548673

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion