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临床试验/NCT04121000
NCT04121000已完成不适用

Effects of Patient Controlled Erector Spinae Block on Postoperative Pain in Video Assisted Thoracoscopic Surgery (VATS) : A Randomized Controlled Study

Bulent Ecevit University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年6月25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
80
试验地点
1
主要终点
Perioperative and postoperative analgesic needs of patients

研究概览

简要总结

In this study our aim is to investigate the effects of continue erector spinae block on postoperative pain in patients who underwent thoracoscopic surgery.

详细描述

Open thoracic surgeries are very painful procedures. After these procedures multimodal analgesia methods such as NSAIDs, opioids, PCA (patient-controlled analgesia), infiltration analgesia and thoracal epidural block are frequently used. Of these methods thoracal epidural block is the gold standart, however this technique is very invasive and has a high risk for complications. Lately Video Assisted Thoracoscopic Surgery (VATS) has become more popular because it reduces the hospital stay and is less invasive, hence the thoracic epidural block for postoperative pain has become more questionable. In this study we aimed to investigate the effects of continue Erector Spinae Block (ESB) on postoperative pain after VATS. The study will include 80 patients.

40 patients will receive ultrasound (USG) guided ESB and 40 patients will receive PCA.

All patients will recive IV Midazolam (0.05mg/kg) premedication. Standard monitorization of EKG, non- invasive blood pressure and pulsoximeter will be done and recorded in every 5 minutes. Fentanyl (1-2 µg/kg), Propofol (2-3 mg/kg) and Rocuronyum (0,5-0,8 mg/kg) will be given in induction of general anesthesia. Volume -controlled ventilation will be secured to have the values O2 saturation >98% and en-tidal carbondioxide 30-35 mm-Hg. For the mainentanance of general anesthesia the minimal alveolar concentration of sevoflurane will be 1. After the surgery every patient will receive 1 gr paracetemol and 100 mg tramadol for postoperative pain. Furthermore every patient will receive 8 mg ondansetrone for postoperative nausesa.

After sedation and standard monitorization, 20 minutes before the induction and in the prone position the Erecor Spinae Block (ESB) procedure will be done. 10 % povidone - iodin will be used for sterilization and the USG probe will be covered with sterile sheath. The block will be done at the 8th thoracic vertebra line. The USG probe will be replaced 2-3 cm lateral to the spinous process in sagittal plane. When the erector spinae muscle is identifed in the USG the needle will be guided caudally. 0.5-1 ml local anesthetics will be given in order to confirm the needle is in the right place. After confirmation with 20 mL %0.25 bupivacaine the procedure will be performed. The patients' VAS scores will be evaluated at the 1st,3rd, 6th, 12th, and 24th hours and will be recorded.

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 (Participant)

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

  • Ages between 20- 75
  • ASA (American Society of Anesthesiologists) Score I-III
  • Undergoing elective Video Assisted Thoracic Surgery

排除标准

  • ASA Score IV and higher
  • Patinets with neurological deficits
  • Paitents who have major vascular damage at the same side
  • Mentally retarded patients
  • Patients with alcohol or drug addiction
  • Patients who are allergic to local anesthetics
  • Pregnancy
  • Paitents with coagulopathy
  • Patients with skin infection at the side of the procedure
  • Patients with pneumothorax at the side of the procedure
  • Patient with a pacemaker

结局指标

主要结局

Perioperative and postoperative analgesic needs of patients

时间窗: Change in VAS scores at the first 48 hours

Our primary outcome is to measure and identify the analgesic needs of the patients at the perioperative and postoperative period.In order to measure the analgesic needs Visual Analogue Scale will be used and patients' pain scores will be measured.

次要结局

  • side effect.(1st, 4rd, 8th,12th, 24th, 36th and 48 th hours after the procedure.)

研究者

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

OZCAN PISKIN, MD

ASSOCIATED PROFESSOR

Bulent Ecevit University

研究点 (1)

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