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The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

2020年1月30日 更新者:Samsung Medical Center

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain.

This study try to find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

研究概览

详细说明

Persistent postoperative pain occurs up to 25 to 60 % after mastectomy. This occurs at a higher frequency than the rate of invasive surgery.Therefore, many ways have been tried to study risk factors. A study was conducted to predict postoperative pain for items (preoperative pain, sensitivity, pain prediction). As a result, it was reported that the scope of surgery, pre-operative pain, young age, and depression were associated with persistent pain.

There were reports of no association with anesthesia in the area of anesthesia to the high pain control requirement in the postoperative recovery room, 24 hours of high pain medication, use of inhalation agent, and a high dosage of remifentanil. However, an anesthesia-related study was either a retrospective study or anesthetic was injected with more than a clinical dose in order to make the difference following methods.

In this study, bispectral index is used to maintain anesthesia depth. In addition, the commercially available noninvasive pain depth equipment (Surgical Pleth Index) is used to assess the nociception-antinociception balance. Displays the automatically calculated values of SPI=100-(0.3*heartbeat interval + 0.7*photoplethysmographic pulse wave ampule) using a waveform with peripheral oxygen saturation. Through this process, patients want to objectify the amount of anesthetic agent used during surgery. And all patients are inserted the laryngeal mask airway.

This study would try find out whether persistent pain after mastectomy is affected anesthetic factors appropriate anesthesia depth and opioid using standardized monitoring devices limited to similar surgical ranges.

The investigators hypothesize that patients who suffered severe acute postoperative pain, regardless of their anesthesia method, have a higher incidence of persistent post-mastectomy pain.

研究类型

观察性的

注册 (实际的)

89

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Gangnam-gu
      • Seoul、Gangnam-gu、大韩民国、06351
        • Samsung Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

取样方法

非概率样本

研究人群

the 20-70 year old patients who undergoing breast conserving surgery + sentinel lymph node dissection at samsung medical center

描述

Inclusion Criteria:

-undergoing breast conserving surgery + sentinel lymph node dissection

Exclusion Criteria:

  • cardiac arrythmia
  • allergic history for drugs
  • renal failure (Cr> 1.5 mg/dl)
  • performing axillary lymph node dissection or Total mastectomy
  • difficult airway and failed to place laryngeal mask airway properly

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
mastectomy group
All patients who received the mastectomy (breast conserving surgery and sentinel lymph node dissection)
All patients assessed postoperative pain score in the recovery room and postoperative 2 month

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
persistent pain
大体时间:postoperative 2 months
persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)
postoperative 2 months
acute postoperative pain
大体时间:postoperative 1 hour
acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)
postoperative 1 hour

次要结果测量

结果测量
措施说明
大体时间
inhalation agent
大体时间:intraoperative
inhalation anesthetics use or total intravenous anesthesia
intraoperative
opioid consumption
大体时间:intraoperative
the amount of opioid
intraoperative
surgical anxiety level
大体时间:1 day before surgery
(0: not anxiety-100: extremely anxious)
1 day before surgery
anticipate pain
大体时间:1 day before surgery
(0: no pain-100: a bad as you can imagine)
1 day before surgery
anticipated pain medication need
大体时间:1 day before surgery
(0: none at all, 1: much less than average, 2: less than average, 3: average, 4: more than average, 5: much more than average)
1 day before surgery
surgery factor
大体时间:intraoperative
the incision size and the number of excision of lymph node
intraoperative
The surgical pleth index
大体时间:intraoperative
the highest surgical pleth index score in time of start anesthesia and ene of anesthesia
intraoperative
The pain score of discharge
大体时间:on the 1 day of discharge
Numeric rating pain score (NSR: no pain=1, worst pain=10)
on the 1 day of discharge
the consumption of postoperative analgesia
大体时间:postoperative 72 hours
the consumption of postoperative analgesia during in-hospital day
postoperative 72 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年12月31日

初级完成 (实际的)

2019年12月5日

研究完成 (实际的)

2019年12月30日

研究注册日期

首次提交

2018年12月19日

首先提交符合 QC 标准的

2018年12月19日

首次发布 (实际的)

2018年12月20日

研究记录更新

最后更新发布 (实际的)

2020年1月31日

上次提交的符合 QC 标准的更新

2020年1月30日

最后验证

2018年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • SMC2018-09-029-003

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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