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


N/A
18 Years
65 Years
Open (Enrolling)
Female
Breast Cancer, Postoperative Pain, Chronic Pain

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Trial Information

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


Inclusion Criteria:



- Age 18 - 65 years.

- ASA 1-2.

- 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

Exclusion Criteria:

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Acute postoperative pain

Outcome Description:

VAS measured in a daily pain diary

Outcome Time Frame:

during 4 days after surgery

Safety Issue:

No

Principal Investigator

M. A Marcus, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Center

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NL34275.068.11 / MEC 11-2-006

NCT ID:

NCT01392248

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Breast Cancer
  • Postoperative Pain
  • Chronic Pain
  • EEG
  • breast cancer surgery
  • prediction
  • acute postoperative pain
  • chronic pain
  • Breast Neoplasms
  • Pain, Postoperative

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