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临床试验/NCT07688395
NCT07688395尚未招募不适用

Novel Analgesic Approaches in Shoulder Surgery: Erector Spinae Plane Block Versus Infraspinatus-Teres Minor Interfascial Plane Block

Taksim Egitim ve Arastirma Hastanesi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Postoperative pain intensity

研究概览

简要总结

The shoulder, being an anatomical region innervated by different nerves, has a wide variety of analgesic approaches, which differ depending on the practitioner. New approaches are being developed based on the different innervation channels demonstrated in clinical and cadaver studies. Over time, the effectiveness of axillary block, suprascapular block, interscalene block, local infiltration, and various combinations, as well as non-regional methods, has been observed. The goal of these approaches is to achieve the highest possible level of patient comfort, high analgesic efficacy, and minimal complications. Studies have shown that the interscalene block has the highest analgesic efficacy and the most ideal postoperative results; therefore, it is frequently used as the gold standard in this field. Providing effective analgesia with a single intervention can also be cited as an aspect that increases patient comfort and simplifies the procedure. In interscalene block; unilateral transient diaphragmatic paralysis due to the spread of local anesthetics to the C7 nerve root, respiratory problems and potential spinal/epidural complications, new approaches are being followed and researched. Results from cervical/high thoracic erector spinae plane block (ESPB) and infraspinatus-teres minor interfascial plane block (ITMIPB) studies, which are the subject of new studies, strengthen the hypothesis that they provide effective analgesia. Neither of these blocks, performed with ultrasonography, carries the risks present in interscalene block. Although the usual risks of a peripheral nerve block are present for these procedures; the block sites are considered safer due to its distance from vascular structures and the reduced risk of additional complications. While small sample studies exist for each type of block, no studies comparing their effectiveness have been found. Besides reduced complications, another advantage of these two blocks is their ability to provide effective analgesia with a single-point injection. The aim of this study is to compare the analgesic efficacy of Cervical Erector Spine Plane Block (ESP) and Infraspinatus-Teres Minor Interfascial Plane Block (ITMIPB) applied for postoperative analgesia in ASA I-III patients undergoing shoulder surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Our study is a single-blind study. Outcome Assessor will be masked to performed block type.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults scheduled for elective shoulder arthroscopy
  • ASA I-II-III patients
  • Patients age between 18-80

排除标准

  • Patients with previously known allergy to local anesthetics.
  • Patients with insufficient pulmonary functions (Severe obstruction or restriction in Pulmonary Function Test)
  • Patients with ASA IV or higher
  • Patients who suffered from any complications related to anesthesia or surgery
  • Patients with additional body part injury
  • Pregnant or breastfeeding women

结局指标

主要结局

Postoperative pain intensity

时间窗: Postoperative 1., 6., 12. and 24. hour

Pain intensity assessed using the 11-point Numeric Rating Scale (NRS; 0=no pain, 10=worst imaginable pain).

次要结局

  • Total postoperative analgesic consumption(24 hours after surgery)
  • Incidence of postoperative nausea and vomiting (PONV)(24 hours after surgery)
  • Block-related complications(24 hours after surgery)

研究者

发起方
Taksim Egitim ve Arastirma Hastanesi
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Canberk Çetinel

Principal Investigator

Taksim Egitim ve Arastirma Hastanesi

研究点 (1)

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