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临床试验/NCT01392248
NCT01392248终止不适用

EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
1
主要终点
Acute postoperative pain

研究概览

简要总结

  1. Rationale The inter-individual pain experience immediately after surgery is considerable. In addition, a number of patients develop chronic post surgery pain (CPSP). Patients undergoing surgery for breast cancer are at risk of developing both acute post surgical pain as well as CPSP. Recently, in a group of patients with chronic back pain, it was demonstrated how subjectively reported pain is associated with specific electroencephalography (EEG) parameters, namely the N2 and P3 components of the pain event-related potential (ERP). It was concluded that ERP was associated with self-reported pain in daily life up to two weeks after the measurement. This resulted in the current hypothesis that EEG may be a predictor for postoperative pain.
  2. Study design Prospective cohort study. Within 2 weeks before surgery, 150 patients will undergo an EEG measurement with five 'vulnerability' tasks. The experiment will be repeated 6 months postoperatively.

Study population: Female patients with breast cancer who will undergo breast surgery, between the ages of 18 to 65 years. 3. Main study parameters/endpoints Primary outcome is postoperative pain, measured in a pain diary 4 days postoperatively. Secondary outcomes are development of chronic post surgery pain and quality of life. The main goal is to develop a comprehensive prediction model for acute and chronic postoperative pain after breast cancer surgery, based on the EEG results of the five vulnerability experiments.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18 - 65 years.
  • Sufficient comprehension of the Dutch spoken and written language.
  • Elective curative breast cancer surgery, both mastectomy and breast- conserving therapy
  • Stage I and II breast cancer.
  • Written informed consent is obtained

排除标准

  • Previous breast surgery, both ipsilateral and contralateral.
  • Stage III-IV breast cancer.
  • Chronic pain (>3months) with an average severity of at least a VAS score 4 during the last two weeks.
  • Chronic pain for which invasive treatment is needed.
  • Use of (weak / strong) opioids in the last week.
  • A history of opioid addiction.
  • Regular use of the following medications in the last year:
  • antiepileptics,antipsychotics and anxiolytics.
  • ASA 3 or higher.
  • Consumption of alcohol (>4 units) and / or drugs the evening before.
  • Alcohol consumption (>= 5 units/day).
  • Illiteracy, problems with self expression, language barrier.
  • Serious vision and / or hearing problems, interfering the performance of the experimental tasks.
  • A history of psychiatric complaints and/or epilepsy .
  • A medical history of CVA or TIA.

结局指标

主要结局

Acute postoperative pain

时间窗: during 4 days after surgery

VAS measured in a daily pain diary

次要结局

  • Development of chronic pain(at 3,6 and 12 months postoperatively)
  • Quality of Life(within 2 weeks before surgery and at 3,6 and 12 months postoperatively)

研究者

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

Carine Vossen

MD

Maastricht University Medical Center

研究点 (1)

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