跳至主要内容
临床试验/NCT04459923
NCT04459923Unknown不适用

The Effects of the Epidural Catheter and Ultrason-guided Erector Spina Plan Block Catheter on Postoperative Pain Scores and Opioid Consumption in Video Assisted Thoracic Surgery

Ataturk University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
VAS

研究概览

简要总结

Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary, mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy can be performed with smaller incisions using video support. While being less invasive in comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain can be more intense than expected after thoracoscopic procedures. Post-operation pain is not just an acute problem; 20% of the patients develop chronic incision pain after a thoracic surgery.

particiants hypothesis is that continue ESP block catheter application is non-inferior than epidural catheter application in the first post-operative 48 hours regarding post-operative pain relief. The purpose of this study is to invertigate the effects of TEA and ESPB on post-operative pain in patients undergoing VATS.

详细描述

Video assisted thoracoscopic surgery (VATS) is a type of minimally invasive thoracic surgery (MITS) procedure used for diagnosis or treatment of chest pathologies (pulmonary, mediastinal, chest wall). Most main procedures traditionally performed by open thoracotomy can be performed with smaller incisions using video support. Literature shows that resections performed with VATS result in shorter hospital stay, lower complication rates, lower mortality rates and similar survivability rates in comparison to thoracotomy. While being less invasive in comparison to open surgery options, thoracoscopic surgery may damage the intercostal nerve and damages muscles. Also it provokes soft tissue edema at the incision area. Therefore, pain can be more intense than expected after thoracoscopic procedures. Post-operation pain is not just an acute problem; 20% of the patients develop chronic incision pain after a thoracic surgery.

Post-operative pain is a type of acute pain which starts with surgical procedure and ends with tissue recovery. Eliminating this pain is one of the important purposes of anaesthesia. Post-operative analgesia methods may prevent the patient from feeling pain, but there has been no consensus regarding pain management, and generally a multi-modal approach is the most preferable approach. While various methods are used for post-operation analgesia, studies to increase patient satisfaction are still ongoing.

Thoracic epidural analgesia (TEA) and paravertebral block are gold standard of analgesia methods for thoracoscopy operations, and these are widely used for VATS procedures. An epidural application generally performed at the level of T5-7 intervertebral space for thoracic surgery. While intra-operative analgesia is also provided using by an epidural catheter, it is also the first preference in post-operative analgesia management. It can be applied by continuous infusion of local anesthetic, or bolus dosages with 4-6 hours intervals.

Erector spina plane block (ESPB) is a type of block applied by injection of a local anaesthetic into the interfacial plane under the erector spina muscle, and it is defined as an analgesic method for thoracic neuropathic pain in 2016. The dermatome area it covers varies according to the level of application. It can be applied under USG guidance and its application may be considered less invasive in comparison to thoracic epidural. Due to its easier application it can prove to be a more popular approach in the future. In thoracic surgeries, single-shut at the T5-6 level can be used or multiple shuts at multiple levels can be applied or continue analgesia can be applied by catheter

  • There has been no randomised controlled study comparing epidural versus erector spinae plane block in the literature.

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, Investigator)

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

入选标准

  • VATS surgery patients
  • ASA I-III group
  • without any chronic pain or anychronic analgesic usage history
  • volunteer to participate in the study

排除标准

  • Patients of ASA IV and above
  • patients with a BMI > 30
  • patients receiving anticoagulant treatments
  • patients having previous neurologic sequellae history
  • patients having previous thoracoctomy history on the same side
  • patients having any allergy against any of the drugs used in the study (paracetamol, non-steroid analgesics and opioids) will be excluded

结局指标

主要结局

VAS

时间窗: 48 hour

difference between average VAS scores of epidural and ESP groups

次要结局

  • Total fentanyl consumption(48 hour)
  • VAS scores(48 hour)

研究者

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

Ilker Ince

Associated Prof MD

Ataturk University

研究点 (2)

Loading locations...

相似试验