Pelvic Bone InjuryRELIEVEDNCT07072286
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 of Pelvic Bone Injury and Pelvis Injury, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Bone Injury, Pelvis Injury, Acetabular Fractures
- What is being tested?
- Regional Anesthesia and Multimodal analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 177 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2024to 25 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Age ≥ 18 years and ability to provide informed consent
- Patients with pelvic/acetabular fractures requiring surgery
Who cannot join
- Age < 18 years
- Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro Traumatologico Ortopedico (CTO) - AOU Città della Salute e della Scienza Univeristy Hospital
Turin, 10126
Marco Ulla, MD, +39-3397548673, marco.ulla@gmail.com
Marco Ulla, MD
About this study
Official 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."
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:
Read more
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
- Being tested
- Regional Anesthesia, Multimodal analgesia
- Keywords
- regional anethesia, pain management, pelvic fractures, acetabular fractures, surgery
- Medical subject headings
- Accidental Injuries, Agnosia, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaProcedure or surgery
- 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 analgesiaDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| RA group | Patients treated with RA techniques in association to multimodal analgesia Receives: Procedure: Regional Anesthesia; Drug: Multimodal analgesia | |
| Multimodal Analgesia Group | Patients treated with multimodal analgesia alone Receives: Drug: Multimodal analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours.
Measured: Up to 24 hours after surgery
Secondary outcomes (5)
Pain Scores
Area under the curve (AUC) of acute pain scores (measured via Numeric Rating Scale - NRS)
Measured: post-operatively at 6, 12, 24 and 48 hours following surgery
Persistent post-surgical pain
Incidence of chronic post-operative/post-traumatic pain assessed via Numeric rating scale (NRS) through telephone follow-up.
Measured: 30, 60, 90-days after surgery
Opioids Side Effects
Incidence of acute side effects related to opioid use (excessive sedation, nausea/vomiting, respiratory depression, pruritus, urinary retention, constipation).
Measured: Up to 48 hours after surgery
RA side effects
Incidence of complications related to nerve blocks (block failure, nerve damage, hematoma, systemic local anesthetic toxicity).
Measured: Up to 48 hours after surgery
Hospital length of stay
Days of admission in the hospital where surgery is provided
Measured: From surgery up to the first follow up at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start25 Jul 2024
- Primary completion25 Oct 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Bone InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072286
- Sponsor's protocol ID
- 00179/2024
- Acronym
- RELIEVED
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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."
- ClinicalTrials.gov ID
- NCT07072286
- Acronym / sponsor ID
- RELIEVED / 00179/2024
- Conditions
- Pelvic Bone Injury, Pelvis Injury, Acetabular Fractures, Acetabular Surgery, Trauma Injury
- Keywords
- regional anethesia, pain management, pelvic fractures, acetabular fractures, surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 25 Oct 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA group | – | Procedure: Regional Anesthesia, Drug: Multimodal analgesiaPatients treated with RA techniques in association to multimodal analgesia |
| Multimodal Analgesia Group | – | Drug: Multimodal analgesiaPatients treated with multimodal analgesia alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Age ≥ 18 years and ability to provide informed consent
- Patients with pelvic/acetabular fractures requiring surgery
Key exclusion criteria (2 listed)
- Age < 18 years
- Absolute contraindications to ALR techniques (uncorrectable coagulopathies, known allergy to local anesthetics, technical impossibility of execution)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | RA group |
| Multimodal analgesiaAll 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. | Drug | Multimodal Analgesia Group, RA group |
Primary outcome
Opioid consumption
Time frame: Up to 24 hours after surgery
Post-operative opioid consumption (morphine milligram equivalents - MMEs) in the first 24 hours.
5 secondary outcomes
Pain Scores
Time frame: post-operatively at 6, 12, 24 and 48 hours following surgery
Persistent post-surgical pain
Time frame: 30, 60, 90-days after surgery
Opioids Side Effects
Time frame: Up to 48 hours after surgery
RA side effects
Time frame: Up to 48 hours after surgery
Hospital length of stay
Time frame: From surgery up to the first follow up at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Bone Injury
Recruiting
Impact of a Clinical Pathway for Pelvic Fragility Fractures
Pelvic Bone Injury, Sacral Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Bone Injury and Pelvis Injury, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Ulla, MD (+39-3397548673, marco.ulla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.