此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

髋部骨折 ED 患者的 PENG 与 FIC 阻滞

2026年9月21日 更新者:Antonios Likourezos

急诊科孤立性髋部骨折患者的囊周神经组 (PENG) 阻滞与髂筋膜室 (FIC) 阻滞

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression.

The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC.

This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.

研究概览

详细说明

Ultrasound-guided nerve blocks are an important tool for treating pain due to orthopedic injury in the ED. They provide long lasting, opioid-sparing pain relief that is generally safe and well-tolerated by patients1. Elderly patients with hip fractures commonly present to the ED, and their injury can be painful. Commonly used opioid pain regimens can have deleterious side effects, especially in elderly patients, like somnolence, delirium, hypotension and respiratory depression.

The fascia iliaca compartment (FIC) block has become a familiar technique to emergency physicians as a pain control treatment for hip fractures. The pericapsular nerve group (PENG) block has recently been proposed as a novel method to treat pain due to hip, acetabular and pelvic fracture by targeting the terminal sensory articular nerve branches of the femoral nerve (FN), obturator nerve (ON), and accessory obturator nerve (AON). At this time there has been no study comparing the efficacy of the two nerve blocks, PENG and FIC.

This aim of this study is to compare the efficacy of the PENG block (20mL of Bupivacaine 0.50%) to that of the FIC block (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED. Our hypothesis is that PENG will demonstrate analgesia that is non-inferior to FIC. Subjective pain scores on a scale of 0 to 10 will be assessed before and after the block. All subjects will receive 4mg of morphine after consent and prior to the block.

A secondary aim is to show that the PENG block is preferable to the FIC block because it does not target motor nerves, thus preserving motor function allowing for an accurate neurological exam and hopefully providing for earlier ambulation. Also, we aim to determine if PENG block results in an significant reduction in amount of systemic pain medication needed for the patient.

This is a single-centered, prospective, randomized, blinded study involving patients who present to the ED with an isolated hip fracture. Patients who meet inclusion criteria will be consented for the study and then randomized to receive either a FIC block or a PENG block. Patients who are potentially to be enrolled in the study will receive standardized systemic analgesia while awaiting x-rays. If needed, patients will be administered morphine for breakthrough pain after the nerve blocks are placed. The exception to this standardization will be patients with a morphine allergy.

The research associate will screen for patients and confirm with the attending physician that the subject is eligible for enrollment and is able to give consent. The patient consented by a member of the research team, who will assess the patient's pain score on a scale of 0 to 10 prior to the block. The patient will then be randomized to receive either the FIC block or the PENG block to be performed by a member of the ultrasound faculty. The research associate will be blinded to the type of block being performed by the ultrasound faculty member. The research associate will then reassess the patient's pain score on the 0-10 scale at the 30 minute and 60-minute mark. They will also assess for any adverse events after the block is performed. The research associate will note the motor function in the quadriceps muscle 30 min and 60 min after the nerve block is placed. Any rescue medication given after the nerve block is placed in the ED will be recorded.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • Brooklyn、New York、美国、11209
        • Maimonides Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 110年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Adult Emergency Medicine Patients over 18 years of age
  • Isolated hip fracture, intertrocanteric or more proximal
  • Pain score 5 or greater on a scale of 0 to 10 just prior to nerve block placement

Exclusion Criteria:

  • Patients with multi-system trauma
  • People who are unable to communicate their level of pain\
  • Pregnant patients
  • Pediatric Patients (less than 18 years of age)
  • Intoxicated Patients
  • Abnormal Vital Signs (HR>120bpm, MAP <65, Pulse Ox <95%)
  • Patients on long term systemic opioid analgesia
  • Allergy to amide local anesthetics

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Fascia Iliaca Compartment

Fascial Iliaca block (FIC) (40mL of Bupivacaine 0.25%) for patients with hip fractures in the ED

Ultrasound Guided Nerve Block for Hip Fracture Patients using the FIC Proceedure

有源比较器:PENG Block

Pericapsular Nerve Group (PENG) Block (20mL of Bupivacaine 0.50%)

Ultrasound Guided Nerve Block for Hip Fractures Patients using the PENG Procedure

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Pain Score at 30 Minutes
大体时间:30 minutes post administration of nerve block

The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 30 minutes post nerve block procedure

30 minutes post administration of nerve block

次要结果测量

结果测量
措施说明
大体时间
Pain Score at 60 minutes
大体时间:60 minutes post administration of nerve block

The pain score at 11 point Likert Scale ranging 0 (no pain) to 10 (very severe pain) at 60 minutes post nerve block procedure

60 minutes post administration of nerve block

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lawrence Haines, MD、Maimonides Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年10月20日

初级完成 (实际的)

2026年5月31日

研究完成 (实际的)

2026年6月21日

研究注册日期

首次提交

2021年10月20日

首先提交符合 QC 标准的

2021年10月20日

首次发布 (实际的)

2021年11月2日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅