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临床试验/NCT02527083
NCT02527083已完成4 期

Influence of Anesthetic Technique on Acute and Chronic Neuropathic Pain

VA Pittsburgh Healthcare System0 个研究点目标入组 10 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
10
主要终点
Pain Score, Chronic

研究概览

简要总结

Research suggests that the type of anesthesia used for surgery may affect intraoperative stress hormone levels. There is also data to support that an increased level of stress hormones leads to increased pain after surgery. The primary aim of this study is to determine the effect of anesthesia type on long term pain after hernia surgery. In this study, patients undergoing inguinal hernia repair will be randomized to an anesthetic group, either Total Intravenous Anesthesia (TIVA) maintained with propofol or Balanced Inhaled Anesthesia (BIA) maintained with sevoflurane. This will allow us to look at any differences in short and long-term pain after hernia repair depending on type of anesthesia received.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • All male patients undergoing herniorrhaphy surgery that requires general anesthesia.

排除标准

  • Subjects unable to communicate directly with the investigators, due to being non-English speaking, loss of hearing, or incompetence.
  • A history of malignant hyperthermia, pseudocholinesterase deficiency, or other disease that prevents anesthetic randomization.
  • Pain-related disorders such as fibromyalgia or other chronic pain syndromes.
  • Emergency surgery.

研究组 & 干预措施

BIA

Active Comparator

Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)

干预措施: Sevoflurane (Drug)

BIA

Active Comparator

Balanced Inhalational Anesthesia (consisting of a sevoflurane inhaled anesthestic only)

干预措施: Remifentanil (Drug)

TIVA-K

Active Comparator

Total intravenous anesthetic with ketamine

干预措施: Propofol (Drug)

TIVA-K

Active Comparator

Total intravenous anesthetic with ketamine

干预措施: Ketamine (Drug)

TIVA-R

Active Comparator

Total intravenous anesthetic with remifentanil

干预措施: Propofol (Drug)

TIVA-R

Active Comparator

Total intravenous anesthetic with remifentanil

干预措施: Remifentanil (Drug)

结局指标

主要结局

Pain Score, Chronic

时间窗: 1 month, 3 months, 6 months, 12 months

Pain as measured by the Intensity Score of the Pain Quality Assessment Scale (PQAS) at each of the time points after surgery. The scale goes from 0 (no pain) to 10 (the most intense pain sensation imaginable). Higher scores mean worse pain.

次要结局

  • Pain Score, Acute(1 day)

研究者

申办方类型
Fed
责任方
Sponsor

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