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临床试验/NCT06480045
NCT06480045已完成不适用

Usage Of Artificial Intelligence-Integrated Usg In Application of Pectoral Block In Mastectomies

Baskent University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年11月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Pain in the postoperative period was evaluated using the VAS score.

研究概览

简要总结

The investigator's goal in this study is to apply PECS II block, before starting surgery, by either conventional USG or artificial intelligence integrated USG to patients who will undergo mastectomy under general anesthesia to determine the effect of the block on hemodynamics and opioid consumption in the intraoperative period. Besides, the investigatorwanted to investigate the contribution of artificial intelligence integrated USG use in the success of a 4-year anesthesiology resident for imaging the injection site.

详细描述

After receiving the approval of the Clinical Research Ethics Committee of Başkent University (KA21/353), 70 patients with ASA I-II, between the ages of 18-75, who were scheduled for mastectomy surgery were included in the study. A 4. year anesthesiology resident under the supervision of two senior anesthesiologists, performed a PECS II block with AI-integrated USG or conventional USG (Group AI-USG and Group USG) after randomization. Although the resident had no experience with pectoral blocks, she had experience with the use of USG and regional anesthesia related to other trunk-area and peripheral blocks. The block was performed after induction of general anesthesia. Patient data in terms of hemodynamic changes in the intraoperative period, opioid (remifentanil) consumption, and postoperatively hemodynamics, pain scores (VAS), postoperative opioid [tramadol administered with a patient-controlled analgesia pump (PCA)] and, if necessary, rescue analgesic agent (non-steroidal antiinflammatory agent) consumption were monitored in the post anesthesia care unit (PACU), and at postoperative 6., 12. and 24.hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •18-70 years
  • •ASA I and II
  • •Underwent mastectomy surgery
  • •Without local anesthetic allergy

排除标准

  • •Patients with ASA III and above
  • •Obesity (body mass index >30)
  • •Psychotropic drug use
  • •Bleeding diathesis
  • •Local anesthetic allergy
  • •Chest wall deformity
  • •Infection at the injection site
  • •Chronic analgesic usage

研究组 & 干预措施

Group AI-USG

Active Comparator

performed a PECS II block with AI-integrated USG

干预措施: Performed PECS II block with AI integrated USG (Procedure)

Group USG

Active Comparator

performed a PECS II block with conventional USG

干预措施: Performed PECS II block with conventional USG (Procedure)

结局指标

主要结局

Pain in the postoperative period was evaluated using the VAS score.

时间窗: 24 hours

The researchers investigate whether postoperative pain increases or decreases, using the VAS score at the postoperative anesthesia care unit, at postoperative 6 hours, 12 hours, and 24 hours.

次要结局

  • Incorporating the use of AI applications reduces the time required to block.(During the procedure.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Çağla Yazar, MD

Principal investigator

Baskent University

研究点 (1)

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