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Clinical Trials/NCT07040423
NCT07040423Not yet recruitingNot Applicable

Evaluation of Local Anesthetic Distribution in the PENG Block Compartment Using Pelvic MRI

Campus Bio-Medico University1 site in 1 country6 target enrollmentStarted: June 1, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
6
Locations
1
Primary Endpoint
Extent of local anesthetic spread as visualized on MRI after PENG block administration

Study Overview

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.

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

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: PENG Block (Procedure)

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.

Intervention: Magnetic resonance imaging (Procedure)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Campus Bio-Medico University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Francesca Gargano

Medical doctor, Anesthesiologist

Campus Bio-Medico University

Study Sites (1)

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