Prediction of Pain After Breast Cancer Surgery With EEG

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01392248
Recruitment Status : Terminated (funding and recruiting problems)
First Posted : July 12, 2011
Last Update Posted : November 28, 2013
Information provided by (Responsible Party):
Carine Vossen, Maastricht University Medical Center

Brief Summary:
  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.

Condition or disease
Breast Cancer Postoperative Pain Chronic Pain

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery
Study Start Date : July 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Acute postoperative pain [ Time Frame: during 4 days after surgery ]
    VAS measured in a daily pain diary

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: within 2 weeks before surgery and at 3,6 and 12 months postoperatively ]
    Quality of Life measured with SF-36

  2. Development of chronic pain [ Time Frame: at 3,6 and 12 months postoperatively ]
    Brief Pain Inventory

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
One hundred and fifty female patients undergoing elective breast cancer surgery in day-case 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01392248

Maastricht UMC
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: M. A Marcus, Prof. Dr. Maastricht University Medical Center
Principal Investigator: J. van Os, Prof. Dr. Maastricht University Medical Center

Responsible Party: Carine Vossen, MD, Maastricht University Medical Center Identifier: NCT01392248     History of Changes
Other Study ID Numbers: NL34275.068.11 / MEC 11-2-006
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: November 28, 2013
Last Verified: November 2013

Keywords provided by Carine Vossen, Maastricht University Medical Center:
breast cancer surgery
acute postoperative pain
chronic pain

Additional relevant MeSH terms:
Breast Neoplasms
Pain, Postoperative
Chronic Pain
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms