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临床试验/NCT03782896
NCT03782896已完成不适用

The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2018年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
1
主要终点
persistent pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • undergoing breast conserving surgery + sentinel lymph node dissection

排除标准

  • 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

结局指标

主要结局

persistent pain

时间窗: postoperative 2 months

persistent postoperative pain after mastectomy (Numeric rating pain score (NSR: no pain=1, worst pain=10)

acute postoperative pain

时间窗: postoperative 1 hour

acute postoperative pain in the recovery room measured by Numeric rating pain score (NSR: no pain=1, worst pain=10)

次要结局

  • surgical anxiety level(1 day before surgery)
  • surgery factor(intraoperative)
  • The surgical pleth index(intraoperative)
  • anticipated pain medication need(1 day before surgery)
  • The pain score of discharge(on the 1 day of discharge)
  • the consumption of postoperative analgesia(postoperative 72 hours)
  • opioid consumption(intraoperative)
  • anticipate pain(1 day before surgery)
  • inhalation agent(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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