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临床试验/NCT07432230
NCT07432230已完成不适用

Evaluation of the Effect of Erector Spinae Plane Block on Cerebral Perfusion in Patients Undergoing One-Lung Ventilation in the Lateral Decubitus Position

Kayseri City Hospital1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Change from baseline in cerebral oxygen saturation (ΔrSO₂) during one-lung ventilation (OLV)

研究概览

简要总结

The aim of this study is to evaluate the effect of the erector spinae plane block, used to reduce postoperative pain, on cerebral oxygenation in thoracic surgery patients undergoing one-lung ventilation in the lateral decubitus position.

详细描述

Pulmonary resection is one of the most frequently performed procedures in thoracic surgery. Lung resections are primarily carried out for the diagnosis and treatment of pulmonary malignancies and, less commonly, for the management of pulmonary bullae, bronchiectasis, complicated infectious lung diseases, and traumatic lung injuries.

During surgery, patients are placed in the lateral decubitus position, and one-lung ventilation (OLV) is employed during both open and endoscopic thoracic procedures to restrict lung movement and to improve surgical exposure and operative conditions.

Thoracotomy is considered one of the most painful surgical procedures in thoracic surgery. It is well established that inadequately controlled intraoperative and postoperative pain adversely affects functional recovery. Despite the use of potent analgesics, patients may experience severe postoperative pain. Consequently, significant hemodynamic instability may occur even under general anesthesia during thoracotomy. In addition, pain may impair respiratory mechanics, leading to atelectasis and other postoperative pulmonary complications.

In the erector spinae plane block (ESPB), anatomical landmarks are identified under ultrasound guidance, and a local anesthetic is administered beneath the erector spinae muscle at the level just above the transverse process of the vertebra, providing thoracic anesthesia. ESPB is frequently used to provide postoperative analgesia in patients undergoing pulmonary surgery in thoracic practice.

It is well recognized that ESPB offers several advantages over traditional techniques performed close to the neuraxis. First, the target structure is easily visualized with ultrasound, and needle advancement toward the target is relatively simple, making the technique easy to perform. In addition, the complication rate associated with this block is relatively low. Critical structures that may result in serious complications if injured-such as the pleura, vascular structures, and the spinal cord-are located away from the needle trajectory. Considering its technical simplicity and relative safety, several authors have suggested that ESPB may be incorporated as a component of multimodal analgesia during the perioperative period.

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 (Participant)

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

  • Patients aged 18-80 years
  • With an American Society of Anesthesiologists (ASA) physical status of I-III
  • Glasgow Coma Scale (GCS) score of 13-15
  • Scheduled for thoracic surgery requiring one-lung ventilation

排除标准

  • Patients undergoing emergency surgery
  • Those younger than 18 years or older than 84 years
  • Patients with an American Society of Anesthesiologists (ASA) physical status of IV or V
  • Patients who refused to participate in the study
  • Those with a history of brain surgery for any reason
  • Patients with defects in the frontal region preventing placement of near-infrared spectroscopy probes
  • Patients with distorted thoracic vertebral anatomy for any reason resulting in inadequate ultrasonographic imaging for block performance
  • Patients with a known allergy to local anesthetics
  • Patients with neurological disorders such as Alzheimer's disease or dementia
  • Patients who were illiterate and/or unable to establish effective communication

研究组 & 干预措施

Study Group

Active Comparator

Patients who received a preoperative erector spinae plane block

干预措施: Erector Spinae Plane Block (Procedure)

Control Group

Placebo Comparator

Patients who did not receive a preoperative erector spinae plane block

干预措施: A preoperative erector spinae plane block will not be administered (Procedure)

结局指标

主要结局

Change from baseline in cerebral oxygen saturation (ΔrSO₂) during one-lung ventilation (OLV)

时间窗: Pre-intubation; intraoperatively at 0, 5, 10, 20, 30, and 60 minutes following intubation; and immediately before and after extubation

Cerebral oxygen saturation (rSO₂, %) will be measured using near-infrared spectroscopy (NIRS). ΔrSO₂ is defined as rSO₂ at each predefined intraoperative time point minus baseline rSO₂

次要结局

  • Incidence of Right Cerebral Desaturation During OLV(Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation)
  • Instantaneous remifentanil requirement during one-lung ventilation (OLV)(Before intubation; during the operation at 0, 5, 10, 20, 30, and 60 minutes after intubation; and immediately before and after extubation)

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ferhunde Yalçın Akçakaya

Medical Resident, Department of Anesthesiology

Kayseri City Hospital

研究点 (1)

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