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临床试验/NCT03650335
NCT03650335Unknown不适用

Effect of Two Different Volumes of Bupivacaine 0.25% Used in Ultrasound-guided Erector Spinae Plane (ESP) Block on Dermatome Spread: A Volume Study

Yuzuncu Yıl University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
postoperative opioid consumption

研究概览

简要总结

To investigate the effect of two different volumes of bupivacaine 0.25% used in ultrasound-guided erector spinae plane (ESP) block on dermatome spread and postoperative analgesia in patients undergoing unilateral thoracotomy

详细描述

The study will have a double-blind design and will be conducted after obtaining an approval from the local ethics committee. The study will include 50 patients planned for thoracotomy, aged 18-65 years with an ASA score of I-II. The patients will be randomized by sealed tender and will be divided into 2 groups with 25 patients each. Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery, patients with a body mass index of 35 or over, patients detected with infection in the intervention site, patients with hematological diseases, patients with a known allergy to local anesthetics, patients that will not provide a written or verbal consent, pregnant patients, and patients with an ASA score of III or IV will be excluded from the study. All the patients will undergo physical examination and their laboratory parameters will be evaluated one day prior to the procedure. Moreover, on the same day, each patient will be informed about dermatome testing (hot/cold), pain prick test (pain test), and pain pump set. Age, body height and weight, duration of block, and duration of surgery will be recorded for each patient

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patients scheduled for elective thoracotomy
  • Aged 18-65 years
  • ASA score of I and II

排除标准

  • Patients that will be transferred to the intensive care unit (ICU) intubated after the surgery,
  • Patients with a body mass index of 35 or over,
  • Patients detected with infection in the intervention site,
  • Patients with hematological diseases,
  • Patients with a known allergy to local anesthetics,
  • Patients that will not provide a written or verbal consent,
  • Pregnant patients
  • Patients with an ASA score of III or IV will be excluded from the study

结局指标

主要结局

postoperative opioid consumption

时间窗: First 24 hours total opioid consumption

Total opioid consumption as microgram/kg will be assessed in 24 hour surgery

次要结局

未报告次要终点

研究者

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

Celaleddin Soyalp

Assist .Prof.

Yuzuncu Yıl University

研究点 (1)

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