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临床试验/NCT04951024
NCT04951024Unknown不适用

Comparison of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block With Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization: A Study to Interleukin-6 and Interleukin-10 Plasma Concentration, Pain Scale, Total Opioid Consumption, and Cardiovascular Stability

Indonesia University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization

研究概览

简要总结

This study aimed to found out The Comparison Of Perioperative Analgesia Effectiveness Between Thoracolumbal Interfascial Plane Block with Erector Spinae Plane Block In Lumbar Posterior Decompression and Stabilization.

详细描述

This is a double blind randomized controlled trial. Forty subject will be recruited with non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do not have exclusion criteria will be asked to sign the informed consent form before included in this study. Subjects will be randomized into two groups. The first group is the group who will get Bilateral Thoracolumbal Interfascial Plane Block after general anesthesia and the second group will be the group who will get Bilateral Erector Spinae Plane Block after general anesthesia. After surgery, pain scale, time to first morphine dose, total morphine consumption in 24 hours, cardiovascular stability and adverse events will be recorded for both group.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 65 years old
  • Patients schedule for elective posterior decompression and stabilization lumbar spine surgery
  • ASA I - III
  • Decompression and posterior stabilization's patients who didn't caused by infection or abscess

排除标准

  • Patients who refuse to participate in this study
  • Body Mass Index < 18,5 kg/m2 and > 27,0 kg/m2
  • Patient with history of chronic opioid
  • Patient with coagulation disorder
  • Patient with cognitive disorders
  • Infection at the injection area

结局指标

主要结局

Change from baseline Interleukin-6 and Interleukin-10 at 6 hours after Lumbar Posterior Decompression and Stabilization

时间窗: Before surgery and 6 hours after surgery

Measure by ELISA

次要结局

  • investigators will record total morphine dose needed in 24 hours(24 hours after surgery)

研究者

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

Aida Rosita Tantri

Doctor

Indonesia University

研究点 (2)

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