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临床试验/NCT03960762
NCT03960762已完成不适用

COMPARISON OF ERECTOR SPINAE PLANE BLOCK AND SERRATUS ANTERIOR PLANE BLOCK FOR POSTOPERATİVE ANALGESIA MANAGEMENT FOLLOWING VIDEO ASSISTED THORACIC SURGERY

Medipol University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Opioid consumption by the patients at postoperative 24 hours period

研究概览

简要总结

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. US-guided serratus anterior plane (SAP) block provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study evaluating the efficacy of ESP block and SAP block following VATS in the literature.

详细描述

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS procedures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption.

The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. The ESP block contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves and creates sensory blockade in both posterior and anterolateral thorax. In the literature, it has been reported that ESP block provides effective analgesia after open heart surgery, breast surgery and ventral hernia repair in randomized controlled studies about ESP block efficiency for postoperative analgesia management. In some case series and case reports it has been reported that ESP block provides effective analgesia after thoracotomy and VATS. Furthermore, it has been reported that it provides effective analgesia in chronic and persistant pain syndromes of thorax.

US-guided serratus anterior plane (SAP) block is an interfascial plane block and was described by Blanco in 2013. A local anesthetic solution is performed into the fascial plane of serratus anterior muscle. It is easy to perform and has low complication rate because it is far away from the important neurological and vascular structures. The serratus anterior muscle may be seen easily with US guidance in the mid-axillary line. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study evaluating the efficacy of ESP block and SAP block following VATS in the literature.

The aim of this study is to compare US-guided ESP block and SAP block for postoperative analgesia management after VATS. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to blocks (pneumothorax, hematoma).

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
Double (Participant, Outcomes Assessor)

盲法说明

Outcomes Assessor and participant will be blinded to the study

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for VATS under general anesthesia

排除标准

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

结局指标

主要结局

Opioid consumption by the patients at postoperative 24 hours period

时间窗: Postoperative 24 hours

Fentanyl using

次要结局

  • Postoperative pain scores(Postoperative 24 hours period)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahadir Ciftci

Primary researcher

Medipol University

研究点 (2)

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