Total Hip Arthroplasty (THA)MRI-PENGNCT07040423
MRI-Based Assessment of Local Anesthetic Spread in the PENG Block Compartment
A study testing PENG Block and Magnetic resonance imaging in people with Total Hip Arthroplasty (THA) and Postoperative Pain Management After Total Hip Arthroplasty, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
This study uses MRI imaging to evaluate the spread of local anesthetic following the administration of a pericapsular nerve group (PENG) block. The goal is to determine whether a distinct fascial plane exists between neurovascular structures, potentially explaining the block's observed clinical effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty (THA), Postoperative Pain Management After Total Hip Arthroplasty
- What is being tested?
- PENG Block and Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2025to Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patients scheduled for total hip replacement surgery
- Age ≥ 18 years
- ASA physical status classification I-III
- Signed informed consent obtained
- Orthopedic indication for preoperative MRI study
Who cannot join
- Allergy to local anesthetics
- Infection at the planned puncture site
- Refusal or inability to provide informed consent
- Age < 18 years
- Claustrophobia
- Altered consciousness or severe dementia
- Presence of MRI-incompatible implanted devices (e.g., pacemakers implanted before 2000)
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Local Anesthetic Distribution in the PENG Block Compartment Using Pelvic MRI
This study uses MRI imaging to evaluate the spread of local anesthetic following the administration of a pericapsular nerve group (PENG) block. The goal is to determine whether a distinct fascial plane exists between neurovascular structures, potentially explaining the block's observed clinical effectiveness.
Read the detailed description
The pericapsular nerve group (PENG) block has demonstrated promising clinical results in providing analgesia for hip-related pain, particularly in patients with femoral neck fractures or undergoing hip surgery. However, the exact mechanism of action and spread of local anesthetic remain poorly understood. This pilot study aims to use magnetic resonance imaging (MRI) to visualize the distribution pattern of the injectate after PENG block administration.
High-resolution MRI scans will be obtained shortly after the procedure to assess the spatial relationship between the spread of local anesthetic, relevant anatomical structures (including the iliopsoas muscle, femoral artery, and femoral nerve), and potential fascial compartments. The findings will help to clarify the anatomic basis of the PENG block and may guide optimization of technique for enhanced clinical outcomes.
- Being tested
- PENG Block, Magnetic resonance imaging
- Keywords
- Anesthetics, Anesthetics, Local, Pain, Acute Pain, PENG block, Pelvic MRI, Regional anesthesia, Fascial plane, Local anesthetic spread
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockProcedure or surgery
Preoperative ultrasound giuded PENG block (ropivacaine 0,5% 20mL)
Magnetic resonance imagingProcedure or surgery
The patient will undergo a pelvic MRI to assess anesthetic diffusion after PENG block
| Study group | Role | What they receive |
|---|---|---|
| PENG Block with MRI-Based Local Anesthetic Spread Assessment | Experimental | All patients receive standardized multimodal analgesia before surgery. Patients in this arm receive an ultrasound-guided PENG block in the supine position under sterile conditions. A low-frequency (2-5 MHz) curvilinear probe is placed above the AIIS and rotated ~45° to align with the pubic ramus. Using an in-plane lateral-to-medial approach, a 10 cm, 20G needle is advanced to the interfascial plane between the iliopsoas tendon and pubic ramus. After negative aspiration, ropivacaine hydrochloride 0.5% is injected in 5 mL increments up to 20 mL, observing spread via ultrasound. A pelvic MRI is then performed to assess anesthetic diffusion before the patient proceeds to total hip arthroplasty. Receives: Procedure: PENG Block; Procedure: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of local anesthetic spread as visualized on MRI after PENG block administration
MRI images will be used to assess the diffusion pattern of local anesthetic following PENG (Pericapsular Nerve Group) block. The assessment will focus on whether the anesthetic reaches a specific fascial plane between the femoral vessels and nerves. A radiologist will evaluate the extent and location of the anesthetic spread in relation to key anatomical landmarks (according to centimeter-based measurements as per MRI protocols).
Measured: 10 minutes after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesca Gargano, Campus Bio-Medico University
- Investigators
- Francesca Gargano, Medical Doctor, Principal investigator, Policlinico Universitario Campus Bio-Medico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040423
- Sponsor's protocol ID
- Policlinico Campus Bio-Medico
- Acronym
- MRI-PENG
- Status last verified
- Jun 2025
- First submitted
- 10 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gargano F, Migliorelli S, Pascarella G, Costa F, Strumia A, Bellezze A, Ruggiero A, Carassiti M. A randomized clinical trial comparing different combination of peripheral nerve blocks for intraoperative analgesia in patients on antithrombotic drugs undergoing hip fracture surgery: pericapsular nerve group (PENG) block versus femoral and obturator nerve block. Minerva Anestesiol. 2025 Jun;91(6):524-532. doi: 10.23736/S0375-9393.24.18534-3. Epub 2024 Dec 10.
PubMed 39656148Nielsen ND, Greher M, Moriggl B, Hoermann R, Nielsen TD, Borglum J, Bendtsen TF. Spread of injectate around hip articular sensory branches of the femoral nerve in cadavers. Acta Anaesthesiol Scand. 2018 Aug;62(7):1001-1006. doi: 10.1111/aas.13122. Epub 2018 Apr 17.
PubMed 29664158Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
PubMed 34196965Sakamoto J, Manabe Y, Oyamada J, Kataoka H, Nakano J, Saiki K, Okamoto K, Tsurumoto T, Okita M. Anatomical study of the articular branches innervated the hip and knee joint with reference to mechanism of referral pain in hip joint disease patients. Clin Anat. 2018 Jul;31(5):705-709. doi: 10.1002/ca.23077. Epub 2018 Apr 16.
PubMed 29577432Lee DJ, Elfar JC. Timing of hip fracture surgery in the elderly. Geriatr Orthop Surg Rehabil. 2014 Sep;5(3):138-40. doi: 10.1177/2151458514537273.
PubMed 25360345
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Local Anesthetic Distribution in the PENG Block Compartment Using Pelvic MRI
- ClinicalTrials.gov ID
- NCT07040423
- Acronym / sponsor ID
- MRI-PENG / Policlinico Campus Bio-Medico
- Keywords
- Anesthetics, Anesthetics, Local, Pain, Acute Pain, PENG block, Pelvic MRI, Regional anesthesia, Fascial plane
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 27 Jun 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.
This study uses MRI imaging to evaluate the spread of local anesthetic following the administration of a pericapsular nerve group (PENG) block. The goal is to determine whether a distinct fascial plane exists between neurovascular structures, potentially explaining the block's observed clinical effectiveness.
Detailed description
The pericapsular nerve group (PENG) block has demonstrated promising clinical results in providing analgesia for hip-related pain, particularly in patients with femoral neck fractures or undergoing hip surgery. However, the exact mechanism of action and spread of local anesthetic remain poorly understood. This pilot study aims to use magnetic resonance imaging (MRI) to visualize the distribution pattern of the injectate after PENG block administration.
High-resolution MRI scans will be obtained shortly after the procedure to assess the spatial relationship between the spread of local anesthetic, relevant anatomical structures (including the iliopsoas muscle, femoral artery, and femoral nerve), and potential fascial compartments. The findings will help to clarify the anatomic basis of the PENG block and may guide optimization of technique for enhanced clinical outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PENG Block with MRI-Based Local Anesthetic Spread Assessment | Experimental | Procedure: PENG Block, Procedure: Magnetic resonance imagingAll patients receive standardized multimodal analgesia before surgery. Patients in this arm receive an ultrasound-guided PENG block in the supine position under sterile conditions. A low-frequency (2-5 MHz) curvilinear probe is placed above the AIIS and rotated ~45° to align with the pubic ramus. Using an in-plane lateral-to-medial approach, a 10 cm, 20G needle is advanced to the interfascial plane between the iliopsoas tendon and pubic ramus. After negative aspiration, ropivacaine hydrochloride 0.5% is injected in 5 mL increments up to 20 mL, observing spread via ultrasound. A pelvic MRI is then performed to assess anesthetic diffusion before the patient proceeds to total hip arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for total hip replacement surgery
- Age ≥ 18 years
- ASA physical status classification I-III
- Signed informed consent obtained
- Orthopedic indication for preoperative MRI study
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Infection at the planned puncture site
- Refusal or inability to provide informed consent
- Age < 18 years
- Claustrophobia
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 |
|---|---|---|
| PENG BlockPreoperative ultrasound giuded PENG block (ropivacaine 0,5% 20mL) | Procedure or surgery | PENG Block with MRI-Based Local Anesthetic Spread Assessment |
| Magnetic resonance imagingThe patient will undergo a pelvic MRI to assess anesthetic diffusion after PENG block | Procedure or surgery | PENG Block with MRI-Based Local Anesthetic Spread Assessment |
Primary outcome
Extent of local anesthetic spread as visualized on MRI after PENG block administration
Time frame: 10 minutes after injection
MRI images will be used to assess the diffusion pattern of local anesthetic following PENG (Pericapsular Nerve Group) block. The assessment will focus on whether the anesthetic reaches a specific fascial plane between the femoral vessels and nerves. A radiologist will evaluate the extent and location of the anesthetic spread in relation to key anatomical landmarks (according to centimeter-based measurements as per MRI protocols).
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 27 Jun 2025.
- Background: PubMed 39656148Gargano F, Migliorelli S, Pascarella G, Costa F, Strumia A, Bellezze A, Ruggiero A, Carassiti M. A randomized clinical trial comparing different combination of peripheral nerve blocks for intraoperative analgesia in patients on antithrombotic drugs undergoing hip fracture surgery: pericapsular nerve group (PENG) block versus femoral and obturator nerve block. Minerva Anestesiol. 2025 Jun;91(6):524-532. doi: 10.23736/S0375-9393.24.18534-3. Epub 2024 Dec 10.
- Background: PubMed 29664158Nielsen ND, Greher M, Moriggl B, Hoermann R, Nielsen TD, Borglum J, Bendtsen TF. Spread of injectate around hip articular sensory branches of the femoral nerve in cadavers. Acta Anaesthesiol Scand. 2018 Aug;62(7):1001-1006. doi: 10.1111/aas.13122. Epub 2018 Apr 17.
- Background: PubMed 34196965Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.
- Background: PubMed 29577432Sakamoto J, Manabe Y, Oyamada J, Kataoka H, Nakano J, Saiki K, Okamoto K, Tsurumoto T, Okita M. Anatomical study of the articular branches innervated the hip and knee joint with reference to mechanism of referral pain in hip joint disease patients. Clin Anat. 2018 Jul;31(5):705-709. doi: 10.1002/ca.23077. Epub 2018 Apr 16.
- Background: PubMed 25360345Lee DJ, Elfar JC. Timing of hip fracture surgery in the elderly. Geriatr Orthop Surg Rehabil. 2014 Sep;5(3):138-40. doi: 10.1177/2151458514537273.
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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.
Francesca Gargano, Medical Doctor principal investigator
Policlinico Universitario Campus Bio-Medico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block and Magnetic resonance imaging in people with Total Hip Arthroplasty (THA) and Postoperative Pain Management After Total Hip Arthroplasty, run by Campus Bio-Medico University 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 5 inclusion and 8 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of local anesthetic spread as visualized on MRI after PENG block administration (time frame: 10 minutes after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07040423, which also lists 5 linked publications.
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 27 Jun 2025.