MRI-Based Assessment of Local Anesthetic Spread in the PENG Block Compartment

NCT07040423 | Not Yet Recruiting DMC

• 1 other identifier: Policlinico Campus Bio-Medico
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Hip Arthroplasty (THA); Postoperative Pain Management After Total Hip Arthroplasty

Keywords

Anesthetics; Anesthetics, Local; Pain; Acute Pain; PENG block; Pelvic MRI; Regional anesthesia; Fascial plane; Local anesthetic spread

Outcome Measures

Primary Outcomes (1)

• 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).

  10 minutes after injection

Study Arms (1)

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.

Procedure: PENG Block; Procedure: Magnetic resonance imaging

Interventions

PENG Block PROCEDURE

Preoperative ultrasound giuded PENG block (ropivacaine 0,5% 20mL)

PENG Block with MRI-Based Local Anesthetic Spread Assessment

Magnetic resonance imaging PROCEDURE

The patient will undergo a pelvic MRI to assess anesthetic diffusion after PENG block

PENG Block with MRI-Based Local Anesthetic Spread Assessment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Policlinico Universitario Campus Bio-Medico

Roma, Italy, 00128, Italy

Location

Related Publications (5)

• 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.

  PMID: 39656148 BACKGROUND

• Nielsen 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.

  PMID: 29664158 BACKGROUND

• Pascarella 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.

  PMID: 34196965 BACKGROUND

• Sakamoto 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.

  PMID: 29577432 BACKGROUND

• Lee 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.

  PMID: 25360345 BACKGROUND

MeSH Terms

Conditions

Pain; Acute Pain

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Francesca Gargano, Medical Doctor

  Policlinico Universitario Campus Bio-Medico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Anesthesiologist

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 27, 2025
• Study Start: June 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

IT (1)