Prediction of Pain After Breast Cancer Surgery With EEG
- 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.
|Study Design:||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|
- Acute postoperative pain [ Time Frame: during 4 days after surgery ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Quality of Life measured with SF-36
- Development of chronic pain [ Time Frame: at 3,6 and 12 months postoperatively ] [ Designated as safety issue: No ]Brief Pain Inventory
|Study Start Date:||July 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: 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|