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临床试验/NCT05993273
NCT05993273已完成不适用

Pain Control After VATS Anatomical Pulmonary Resections: Randomized Comparison Between Cryoanalgesia, Erector Spinae Plane Block and Epidural Catheter

University Hospital Padova2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Post-operative pain

研究概览

简要总结

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.

In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.

Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.

The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.

详细描述

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), moderate to severe post-operative pain may often be experienced. The presence of pain negatively affects the perceived quality of care and can predispose to complications, as the development of chronic pain.

In order to prevent post-operative pain, different multimodal pain treatment protocols are applied, consisting in combinations of local-regional anesthesiological techniques and intravenous medications.

Regional anesthesia is considered essential to prevent pain in the immediate post-operative period. However, to date, there is no agreement regarding which is the most effective regional anesthesiological technique; therefore, the choice is usually based on the Anesthetist's preferences.

The aim of this study is to compare three regional anesthesiological techniques (cryoanalgesia, epidural anesthesia, and erector spinae muscle plane block) routinely used during thoracoscopic lung surgery.

All patients undergoing anatomical pulmonary resections (lobectomy or segmentectomy) through a thoracoscopic (VATS) approach, and who present the inclusion/exclusion characteristics, will be considered.

研究设计

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

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

  • all patients undergoing VATS anatomic pulmonary resection (lobectomy or segmentectomy) for benign or malignant disease

排除标准

  • Refusal or inability to give informed consent to the study protocol
  • Age < 18 years
  • Pregnancy
  • Allergies or contraindications to any of the treatments considered in the experimental design
  • Pre-operative use of pain medication for chronic pain or neuropathic pain
  • History of previous major chest surgery
  • American Society of Anesthesiologists (ASA) class > 3
  • Need for intensive care unit stay in the post-operative period
  • Patients undergoing anatomical pulmonary resections different than lobectomy or segmentectomy (bi-lobectomy or pneumonectomy).
  • Patients undergoing bronchial and/or vascular resections and reconstructions

结局指标

主要结局

Post-operative pain

时间窗: 24 hours after surgery

Perceived post-operative pain 24 hours after surgery through Numeric Pain Rating Scale (NPRS, value from 0 to 10, o=no pain, 10=worst pain ever)

次要结局

  • Post-operative pain trend(1,6,12 and 48 hours after surgery)
  • Rescue Analgesia(48 hours after surgery)

研究者

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

Giovanni Maria Comacchio

Thoracic Surgeon

University Hospital Padova

研究点 (2)

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