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临床试验/NCT06778161
NCT06778161已完成不适用

Clinical Research Ethic Committee of Gaziantep University

Elzem SEN1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年10月1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
发起方
入组人数
130
试验地点
1
主要终点
Visual Analog Scale

研究概览

简要总结

This study aims to compare the postoperative analgesic efficacy of ultrasound-guided erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) in patients undergoing thoracotomy. The primary outcome is the VAS scores assessed at postoperative hours 0, 3, 6, 12, and 24 for pain at rest. The secondary outcome was tramadol and morphine consumption.

详细描述

This study is a retrospective study conducted after obtaining approval from the Clinical Research Ethics Committee (decision no: 2021/241, dated 07/07/2021). It was carried out by reviewing the recorded data of patients who underwent thoracotomy surgery in the Department of Anesthesiology and Reanimation at Gaziantep University Faculty of Medicine Şahinbey Research and Application Hospital between October 1, 2020, and May 31, 2021. The study was conducted in accordance with the "Ethical Principles for Medical Research Involving Human Subjects" outlined in the Declaration of Helsinki published by the World Medical Association in 2013.

This study included a total of 130 patients, aged 18-75 years, with ASA physical status scores of I, II, or III, who underwent thoracotomy surgery and received ultrasound-guided ESPB or TPVB for postoperative analgesia. Written informed consent was obtained from all participants. Patients were excluded from the study if they were emergency cases, had an ASA class IV or V status, had peripheral vascular disease, were pregnant, had heart failure, were allergic to local anesthetics, or if their medical records were inaccessible.

The patients were divided into two groups of 65 individuals each, based on the type of regional analgesia administered for thoracotomy. The groups were designated as Group 1 (patients who received ESPB) and Group 2 (patients who received TPVB). Data on patients' age, gender, ASA classification, height, body weight, BMI, comorbidities, smoking status, indication for thoracotomy, thoracotomy side, duration of operation, postoperative 0th, 3rd, 6th, 12th, 24th. VAS scores, average tramadol and morphine consumption, and the presence of postoperative nausea, pruritus, and shoulder pain were collected retrospectively from medical records.

A 20-gauge peripheral venous access was provided in the operating room, and a balanced electrolyte solution was initiated at 3-5 ml/kg/hour. After completing monitoring with electrocardiography (ECG), pulse oximetry (SpO2), and non-invasive arterial pressure (mmHg), 0.03 mg/kg midazolam (Zolamid 15 mg/3 ml, VEM İlaç, Ankara/Turkey) was administered to provide sedation. Intravenous induction was performed with 2 mg/kg propofol (Propofol Lipuro 1% 200 mg/20 ml, B. Braun Medikal Dış Ticaret A.Ş., Esenler/Istanbul), 1 μg/kg fentanyl (Talinat ampoule 0.5 mg/10 ml, VEM İlaç San. ve Tic A.Ş, Çankaya/Ankara), and 6 mg/kg rocuronium (Esmeron® vial 50 mg/5 ml, Merck Sharp Dohme İlaçları Ltd. Şti., Levent/Istanbul). Female patients were intubated with 35Fr and male patients with 37Fr double-lumen endotracheal tubes (Teleflex Medical, Sheridan® Sher-i-Bronch® Endobronchial Tube). Fiberoptic bronchoscopy was used to confirm the correct placement of the endobronchial tube. After the intubation procedure, all patients underwent radial artery catheterization and subclavian central venous catheterization using a 3-lumen, 8.5F central venous catheter (Gemed Sağlık Ürünleri San. Tic. Ltd. Şti., Kartal/Istanbul).

During the perioperative period, a lung-protective mechanical ventilation strategy was employed during both double-lung ventilation and single-lung ventilation. Anesthesia maintenance was initiated with sevoflurane (Sevorane® Liquid 100%, Baxter Turkey Renal Services Inc., Ostim/Ankara) at a rate of 2 L/min in a mixture of 55% air and 45% oxygen, maintaining a minimum alveolar concentration (MAC) between 1.0 and 1.5. For intraoperative analgesia, remifentanil (Rentanil® vial containing 5 mg lyophilized powder, VEM İlaç San. ve Tic A.Ş, Çankaya/Ankara) was started at a dose of 0.15 mcg/kg/min. Throughout the operation, EtCO2 levels were maintained between 30-35 mmHg.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who had undergone thoracotomy, with ASA I,II,III physical status and received ESP block or paravertebral block

排除标准

  • •Patients were excluded from the study if they were emergency cases, had an ASA class IV or V status, had peripheral vascular disease, were pregnant, had heart failure, were allergic to local anesthetics, or if their medical records were inaccessible.

研究组 & 干预措施

paravertebral block group

Other

干预措施: nerve block (Procedure)

erector spinae block group

Other

干预措施: nerve block (Procedure)

结局指标

主要结局

Visual Analog Scale

时间窗: Postoperative 0., 3., 6., 12., ve 24. hour

Visual analog scale, is one of the pain rating scales, providing a range of scores from 0-100.

次要结局

  • side effects(Postoperative 24 hours)

研究者

发起方
Elzem SEN
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Elzem SEN

Assoc.Prof.

University of Gaziantep

研究点 (1)

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