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临床试验/NCT07482449
NCT07482449已完成不适用

Comparison of the Effectiveness of Ultrasound-Guided Bilateral Erector Spinae Plane Block and Thoracic Epidural Analgesia Methods in Patients Undergoing Thoracotomy

Denizhan Acar1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年5月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Comparison of the analgesic efficacy of regional techniques

研究概览

简要总结

Effective control of severe post-thoracotomy pain is pivotal for minimizing pulmonary complications and enhancing patient comfort. This prospective, randomized, three-arm study compared the analgesic efficacy of ultrasound-guided bilateral erector spinae plane block (ESPB) and thoracic epidural analgesia (TEA) with conventional intravenous opioid-based care. Seventy-two ASA I-II patients aged 18-80 years undergoing elective thoracotomy were block-randomized to receive TEA, ESPB, or no regional intervention (control). All procedures were performed at the end of surgery before emergence from anesthesia. Pain intensity was assessed at 1, 2, 4, 6, 12, and 24 h postoperatively using the Visual Analog Scale (VAS). Additional outcomes included time to first rescue opioid, total tramadol consumption, time to modified Aldrete score (MAS) ≥ 9, patient satisfaction, and length of hospital stay.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • ASA I-II, Age Range 18-80 years old

排除标准

  • GKS < 15 LIVER, HEART, LUNG, KIDNEY FAILURE PREGNANCY TRAUMA NEUROLOGICAL DEFICIT

结局指标

主要结局

Comparison of the analgesic efficacy of regional techniques

时间窗: THE FIRST 24 HOURS AFTER THORACOTOMY SURGERY

The analgesic efficacy of TEA and ESP blocks after thoracotomy surgeries was evaluated at 1, 2, 4, 6, 12, and 24 hours postoperatively in terms of VAS scores and analgesic drug consumption. The frequency and amount of tramadol and fentanyl analgesic drug consumption were recorded in the postoperative period. VAS scores were monitored at the specified times. The results were compared, and analgesic efficacy was evaluated. In addition, patient satisfaction (1: excellent, 2: good, 3: moderate, 4: poor), intensive care unit and hospital stay, and postoperative recovery time (using the modified aldarate score) were evaluated.

次要结局

未报告次要终点

研究者

发起方
Denizhan Acar
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Denizhan Acar

research assistant doctor

Trakya University

研究点 (1)

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