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临床试验/NCT07040423
NCT07040423尚未招募不适用

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

Campus Bio-Medico University1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
6
试验地点
1
主要终点
Extent of local anesthetic spread as visualized on MRI after PENG block administration

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 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.

干预措施: Magnetic resonance imaging (Procedure)

结局指标

主要结局

Extent of local anesthetic spread as visualized on MRI after PENG block administration

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Gargano

Medical doctor, Anesthesiologist

Campus Bio-Medico University

研究点 (1)

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