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临床试验/NCT07782073
NCT07782073进行中(未招募)不适用

A Prospective Comparison of Continues Catheter Paravertebral Block vs Continues Catheter Erector Spinal Block in Patients Undergoing Robotic Assistant Thoracic Surgery

Soroka University Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Post operative opioid consumption

研究概览

简要总结

The overall goal of this work is to find the preferred continues catheter- based thoracic block for patients who undergoing major ROBOTIC assisted thoracic surgery (Lobectomy, multiple segmental resection and thoracotomy). Specifically, this project aims to complete the following:

  1. To compare analgesic efficiency of continuous TPVB vs ESP block in patients undergoing major robotic thoracoscopic operation
  2. To assess failure rate, time to catheter placement and patient satisfaction of each block group
  3. To compare complication rate of each block

详细描述

All adult patients undergoing major robotic thoracic procedures, such as Lobectomy, multiple segmental resection and thoracotomy. The recruitment period is planned for approximately 1 year. The follow-up period will be from admission until hospital discharge.

Video-assisted thoracic surgery (VATS) is a type of minimally invasive thoracic surgery that can remove parts of the diseased lung and lymph nodes. In video-assisted thoracoscopic surgery (VATS), a small tube called a thoracoscope is inserted through a small cut (incision) between the ribs. At the end of the tube is a small camera. This lets the surgeon see the entire chest cavity without having to open up the chest or spread the ribs. The surgeon then removes lung tissue with specially designed instruments inserted through one or two additional small incisions. The VATS technique can be used for other types of chest procedures involving the lungs, esophagus, thymus, pleural or pericardium besides lung cancer surgery.

Thoracic paravertebral block (TPVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramina. This results in ipsilateral somatic and sympathetic nerve blockade in multiple contiguous thoracic dermatomes above and below the site of injection

In recent years a new conceptual type of regional anesthesia has emerged: the Erector Spinae Plane Block (ESP block). Originally it was described in 2016 in a case report regarding analgesia intervention for thoracic neuropathic pain. Since then, there has been growing interest and research adding experience about the ESP block for pain control after thoracic and abdominal surgery and also traumatic injury of chest and abdomen. Current literature is limited to approximately 60 publications, the majority of which is case reports and case series.

Comparison of both techniques:

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
Single (Investigator)

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

  • Age ≥18 years
  • All patients undergo major robotic thoracic surgery

排除标准

  • Patients who refuse to participate in the study.
  • Patients who are unable to give an informed consent.
  • Patients with local inflammation at the puncture site
  • Patients with known allergy to local anesthetisc
  • Pregnancy

结局指标

主要结局

Post operative opioid consumption

时间窗: From completion of surgery through hospital discharge, assessed up to 24 hours postoperatively

measured by MME (morphine equivalent)

post operative pain

时间窗: Every 2 hours starting from PACU admission until hospital discharge, assessed up to 96 hours postoperatively.

measured by Visual Analog Scale (VAS); measured from 0 to 5, when 5- is maximal pain and 0 - no pain at all.

次要结局

  • Patient satisfaction(immediately before discharge from the hospital)

研究者

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

Alexander Smirnov MD

Attending Physician, Anesthesia and acute pain service; Principal Investigator.

Soroka University Medical Center

研究点 (1)

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