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临床试验/NCT04303585
NCT04303585Unknown不适用

Blocco Del Dentato Anteriore e Blocco Del Muscolo Erettore Della Colonna Vertebrale Nella Gestione Multimodale Del Dolore in Chirurgia Toracica Mininvasiva: Studio Osservazionale Prospettico Multicentrico

University of Trieste3 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2019年6月27日最近更新:
适应症

试验速览

阶段
不适用
入组人数
170
试验地点
3
主要终点
Morphine consumption

研究概览

简要总结

Thoracic surgery is characterized by acute perioperative pain. There are different ways to provide analgesia, such as intravenous analgesics (opioids or non-opioids) or loco-regional procedures; these techniques are often used together in the context of a multimodal approach to pain management, in order to exploit their synergistic action and minimize side effects. In this observational prospective multicentric study the investigators evaluate the effectiveness of two routinely administered ultrasound guided loco-regional analgesic techniques in providing analgesia to patients undergoing mini-invasive lung-resective thoracic surgery. The two techniques compared are the serratus anterior plane (SAP) block and the erector spinae plane (ESP) block.

详细描述

Whatever the loco-regional technique is (SAP block or ESP block), it must have been administered in the immediate preoperative phase; both procedures are routinely used for analgesic purpose in the clinical practice of the three centers involved in the study and are performed under ultrasound guide. Using medical records, data collected by Acute Pain Service nurses and patients' interviews useful data will be collected: demographic and clinical characteristics (age, sex, weight, comorbidities), surgical data (type of procedure, surgical approach and duration of surgery) and anesthesia data (type of block, dose and type of local anesthetic with record of potential side effects), intraoperative and postoperative opioid and non-opioid analgesic consumption (and rescue if needed) with record of potential side effects, pain evaluation in the first 24 hours after surgery and after at 3 months.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Lung-resective thoracic surgery (lobectomy, bilobectomy, segmentectomy and wedge resection) with videothoracoscopic or mini-thoracotomic approach (maximum duration 180 minutes)
  • BMI ranging from 18 to 30
  • Age > 18 years
  • ASA I-III
  • Ultrasound guided preoperative ESP block or SAP block
  • Remifentanil as intraoperative opioid

排除标准

  • Patient's refusal
  • Weight < 50 kg
  • Pregnancy
  • Emergent surgery
  • Chronic opioid therapy
  • History of drug or benzodiazepine addiction or alcohol abuse
  • Previous thoracic surgery

结局指标

主要结局

Morphine consumption

时间窗: First 24 hours after surgery

Evaluation of morphine consumption in the first 24 hours after surgery

次要结局

  • Intraoperative opioid consumption(Duration of surgical procedure)
  • Numeric Rating Scale (NRS)(First 24 hours after surgery, then after 3 months)
  • Analgesic rescue and corticosteroids(First 24 hours after surgery)
  • Side effects(First 24 hours after surgery)

研究者

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

Marzia Umari

Principal Investigator

University of Trieste

研究点 (3)

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