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.
ClinicalTrials.gov Identifier: NCT01392248
Recruitment Status :
(funding and recruiting problems)
First Posted : July 12, 2011
Last Update Posted : November 28, 2013
Maastricht University Medical Center
Information provided by (Responsible Party):
Carine Vossen, Maastricht University Medical Center
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.
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
One hundred and fifty female patients undergoing elective breast cancer surgery in day-case surgery.
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
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 .