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Classic Versus Interfascial Axillary Block in Hand, Wrist, and Forearm Surgery

2026年9月14日 更新者：Korgün Ökmen、Bursa Yuksek Ihtisas Training and Research Hospital

Comparison of Axillary Block and Interfascial Axillary Block in Terms of Block Success and Intraoperative Clinical Efficacy in Hand, Wrist, and Forearm Surgery: A Prospective Randomized Study

Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. In the conventional (classic) axillary block, the median, ulnar, and radial nerves within the axillary sheath are individually targeted under ultrasound guidance; however, anatomical septations around the axillary artery may prevent homogeneous spread of local anesthetic, leading to a patchy block and reduced intraoperative success.

The interfascial axillary block is a modified approach in which local anesthetic is deposited into the fascial planes between the axillary muscles rather than directly into the nerve sheath, aiming for passive diffusion, homogeneous spread, and fewer needle manipulations. This prospective, randomized, single-center study compares the classic axillary block with the interfascial axillary block in patients undergoing hand, wrist, and forearm surgery, primarily in terms of surgical anesthesia adequacy (block success).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This is a prospective, randomized, single-center clinical trial conducted in a Department of Anesthesiology and Reanimation. Randomization is performed using the sealed-envelope method. A total of 110 patients (55 per group) aged 18-90 years, American society of anesthesiologists physical status I-III, scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided regional anesthesia will be enrolled.

Group 1 (Classic Axillary Block) receives an ultrasound-guided block targeting the median, ulnar, and radial nerves perineurally/perivascularly within the axillary sheath. Group 2 (Interfascial Axillary Block) receives an ultrasound-guided injection of local anesthetic into the potential fascial planes between the axillary muscles, relying on passive diffusion.

The primary outcome is surgical anesthesia adequacy (block success). Secondary outcomes include block application time, sensory and motor block onset, rates of additional local infiltration and conversion to general anesthesia, intraoperative additional analgesic/sedation requirements, hemodynamic parameters, patient and surgeon satisfaction, and complications.

研究类型

介入性

注册 (估计的)

110

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。

学习联系方式

学习地点

  • 土耳其（türkiye）
      • Bursa、土耳其（türkiye）、16110
        • Bursa Yuksek Ihtisas Training and Research Hospital

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Aged 18-90 years
  • American society of anesthesiologists physical status I-II-III
  • Scheduled for elective hand, wrist, or forearm surgery
  • Written informed consent obtained

Exclusion Criteria:

  • History of local anesthetic allergy
  • Coagulation disorder
  • BMI > 40 kg/m²
  • Infection at the block site
  • Chronic pain syndrome
  • Pregnancy
  • Inability to communicate
  • Need for emergency surgery

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：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Classic Axillary Block
Ultrasound-guided classic axillary brachial plexus block. The median, ulnar, and radial nerves within the axillary sheath around the axillary artery are targeted individually by perineural/perivascular injection of local anesthetic.
程序：Classic Axillary Block
Classic (perivascular/perineural) axillary brachial plexus block
有源比较器：Interfascial Axillary Block
Ultrasound-guided interfascial axillary block. Local anesthetic is injected into the potential fascial planes between the axillary muscles rather than directly into the nerve sheath, allowing passive diffusion of the drug.
程序：Interfascial Axillary Block
Interfascial (fascial-plane) axillary brachial plexus block.

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
Surgical anesthesia adequacy (block success)
大体时间：30 minutes after block
Complete sensory and motor blockade of the surgical field, allowing the operation to be completed without additional local infiltration or conversion to general anesthesia
30 minutes after block

次要结果测量

结果测量
措施说明
大体时间
Block application time
大体时间：intraoperative
time from needle insertion to withdrawal.
intraoperative
Sensory block onset time
大体时间：5., 10., 15., 30. minutes
Pin-Prick test in the median, ulnar, radial, and musculocutaneous dermatomes (0: normal, 1: blunt, 2: no sensation).
5., 10., 15., 30. minutes
Motor block onset time
大体时间：5., 10., 15., 30. minutes
5., 10., 15., 30. minutes
Intraoperative additional analgesic/sedation consumption
大体时间：intraoperative
intraoperative
Patient and surgeon satisfaction
大体时间：end of surgery
4-point Likert scale (1: very poor, 4: very good)
end of surgery

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。

赞助

Bursa Yuksek Ihtisas Training and Research Hospital

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 (估计的)

2026年10月15日

初级完成 (估计的)

2027年9月15日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年9月9日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • BursaYIEAH-2026-1

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.

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