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Injection Site in Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy (ISB-ROOT)

2026年7月5日 更新者：Hakan Emirkadı、Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Does the Injection Site of Local Anesthetic Around the C5-C7 Nerve Roots Affect Block Success and Complication Rates During Ultrasound-Guided Interscalene Block for Shoulder Arthroscopy?

Ultrasound-guided interscalene block is commonly used for postoperative analgesia in patients undergoing shoulder arthroscopy. The location of local anesthetic injection may influence both block efficacy and the incidence of block-related complications. This randomized, double-blind clinical trial compares two different injection sites around the C5-C7 nerve roots using the same local anesthetic dose and volume. The study will assess block success, postoperative analgesia, opioid consumption, diaphragmatic function, and procedure-related complications.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Patients scheduled for elective shoulder arthroscopy under general anesthesia will be randomly assigned to one of two ultrasound-guided interscalene block techniques. In one group, the local anesthetic will be injected between the C5-C7 nerve roots and the anterior scalene muscle. In the other group, the injection will be performed between the C5-C7 nerve roots and the middle scalene muscle. The same local anesthetic solution, volume, and concentration will be used in both groups.

Block success, postoperative pain control, opioid consumption, diaphragmatic movement assessed by ultrasonography, and block-related complications including vascular puncture, Horner syndrome, hoarseness, dyspnea, nausea, vomiting, and prolonged motor block will be recorded and compared between the groups.

研究类型

介入性

注册 (估计的)

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。

学习联系方式

学习地点

  • 土耳其（türkiye）
    • Istanbul
      • Istanbul、Istanbul、土耳其（türkiye）、34668
        • Sultan Abdulhamid Han Training and Research Hospital
        • 接触：

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:

Adults aged 18 years or older. ASA physical status I-III. Scheduled for shoulder arthroscopy under general anesthesia with a planned ultrasound-guided interscalene block for postoperative analgesia.

Able to provide written informed consent. Normal coagulation parameters and no antithrombotic therapy. No infection or anatomical abnormality at the injection site. No known allergy to local anesthetics. No contralateral diaphragmatic paralysis or pneumothorax. No dyspnea and adequate pulmonary function.

Exclusion Criteria:

Age younger than 18 years or ASA physical status IV. Antithrombotic therapy or abnormal coagulation parameters. Infection or anatomical abnormality at the injection site. Known allergy to local anesthetics. Contralateral diaphragmatic paralysis or history of pneumothorax. Dyspnea. Refusal to undergo interscalene block.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Anterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the anterior scalene muscle.
程序：Ultrasound-Guided Interscalene Block
Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia. Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.
实验性的：Posterior Interscalene Block
Ultrasound-guided interscalene block with local anesthetic injected between the C5-C7 nerve roots and the middle scalene muscle.
程序：Ultrasound-Guided Interscalene Block
Ultrasound-guided interscalene brachial plexus block performed before induction of general anesthesia. Participants are assigned to one of two injection sites around the C5-C7 nerve roots according to the randomized study protocol.

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
Postoperative Analgesic Efficacy
大体时间：12 hours after surgery
Postoperative analgesic efficacy will be assessed using patient-controlled analgesia demand and delivered dose counts and the need for rescue analgesia.
12 hours after surgery

次要结果测量

结果测量
措施说明
大体时间
Time to First Rescue Analgesic
大体时间：12 hours after surgery
Time from the end of surgery to first rescue analgesic administration.
12 hours after surgery
Hemidiaphragmatic Paralysis
大体时间：Before block and 2 hours after surgery
Presence of ipsilateral hemidiaphragmatic paralysis assessed by ultrasonography.
Before block and 2 hours after surgery
Block-Related Complications
大体时间：During block placement and within 12 hours after surgery
Incidence of vascular puncture, intraneural injection, Horner syndrome, dyspnea, hoarseness, nausea, vomiting, recurrent laryngeal nerve block, stellate ganglion block, and prolonged motor block.
During block placement and within 12 hours after surgery
Block Duration
大体时间：12 hours after surgery
Duration of sensory and motor block recorded during postoperative follow-up.
12 hours after 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

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

调查人员

  • 首席研究员：Tuna Erturk, MD、Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

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7月15日

初级完成 (估计的)

2026年11月10日

研究完成 (估计的)

2026年11月30日

研究注册日期

首次提交

2026年7月5日

首先提交符合 QC 标准的

2026年7月5日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月5日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 21-19

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because no data sharing plan has been established for this investigator-initiated study.

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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