Prediction of Pain After Breast Cancer Surgery With EEG
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|ClinicalTrials.gov Identifier: NCT01392248|
Recruitment Status : Terminated (funding and recruiting problems)
First Posted : July 12, 2011
Last Update Posted : November 28, 2013
- 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.
|Condition or disease|
|Breast Cancer Postoperative Pain Chronic Pain|
|Study Type :||Observational|
|Actual Enrollment :||4 participants|
|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|
- Acute postoperative pain [ Time Frame: during 4 days after surgery ]VAS measured in a daily pain diary
- 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
- Development of chronic pain [ Time Frame: at 3,6 and 12 months postoperatively ]Brief Pain Inventory
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 ClinicalTrials.gov identifier (NCT number): NCT01392248
|Maastricht, Limburg, Netherlands, 6200 MD|
|Principal Investigator:||M. A Marcus, Prof. Dr.||Maastricht University Medical Center|
|Principal Investigator:||J. van Os, Prof. Dr.||Maastricht University Medical Center|