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临床试验/NCT07398352
NCT07398352招募中不适用

Comparison Of The Effect Of Interscalene Block Alone And The Combination Of Interscalene Block And Superficial Cervical Block On Brain Oxygenation And Carotid Artery Diameter In Shoulder Surgery

Sanliurfa Mehmet Akif Inan Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年2月23日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
The effect of regional anesthesia on cerebral oxygenation

研究概览

简要总结

The aim of our study was to compare the effects of interscalene block alone and the combination of interscalene block and superficial cervical block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, laboratory parameters, clinical course and postoperative pain in patients undergoing shoulder surgery.

详细描述

This study aimed to compare the effects of interscalene block alone and interscalene block combined with superficial cervical plexus block on cerebral oxygenation, carotid artery diameter, intraoperative hemodynamics, and postoperative pain in patients undergoing shoulder surgery.

Peripheral nerve blocks, particularly interscalene block, are commonly used in shoulder surgery due to their superior analgesic efficacy. Cerebral oxygenation was assessed using near-infrared spectroscopy (NIRS), a non-invasive method that reflects regional tissue oxygenation. The effects of both block techniques on bilateral cerebral oxygenation and carotid artery diameter were evaluated using NIRS and ultrasonography, respectively

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years patient
  • American Society of Anesthesiologists (ASA) I-II patient

排除标准

  • Age < 18 years or > 65 years
  • History of carotid endarterectomy
  • History of cerebrovascular accident(CVA)
  • Body Mass index (BMI)>35 kg/m²
  • Inability to cooperate or comply with study procedures
  • Liver and kidney failure
  • Pregnancy and breastfeeding
  • ASA pyhsical status III-V
  • Contraindication to regional anesthesia

研究组 & 干预措施

interscalene brachial plexus block

Active Comparator

The effect of interscalene block on cerebral perfusion and carotid diameter in shoulder surgery

干预措施: Interscalene brachial plexus block (Procedure)

Combination of superficial cervical plexus block and interscalene brachial plexus block.

Experimental

Effects of combined interscalene block and superficial cervical block on cerebral perfusion and carotid diameter in shoulder surgery

干预措施: Interscalene brachial plexus block and superficial cervical plexus block (Procedure)

结局指标

主要结局

The effect of regional anesthesia on cerebral oxygenation

时间窗: Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute

We plan to investigate the effect of interscalene block or a combination of interscalene and superficial cervical block on oxygenation of both hemispheres of the brain using a NIRS probe.

次要结局

  • The effect of regional anesthesia on carotid artery diameter(Before block; T1 After block; T2: 5. minute, T3: 10. minute, T4: 15 minute, T5: 20 minute / In the beach chair position; T6: 1. minute, T7: 10. minute, T8: 30. minute, T9: 60. minute, T10: surgical end, Postoperative supine; T11: 5. minute)
  • The effect of the two-block method on the duration of first postoperative analgesia requirement and opioid consumption(From the end of surgery until the first request for postoperative analgesia and the amount of opioid comsumption, assessed up to 24 hours postoperatively)

研究者

发起方
Sanliurfa Mehmet Akif Inan Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

RAMAZAN ASLANPARÇASI

Specialist Of Anesthesiology And Reanimation

Sanliurfa Mehmet Akif Inan Education and Research Hospital

研究点 (1)

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