Clinical trial NCT01392248: Prediction of Pain After Breast Cancer Surgery With EEG
Official title: EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Postoperative Pain
Chronic Pain
Keywords: EEG
breast cancer surgery
prediction
acute postoperative pain
chronic pain
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and fifty female patients undergoing elective breast cancer surgery in day-case surgery.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Acute postoperative pain
timeFrame: during 4 days after surgery
Secondary outcomes:
measure: Quality of Life
timeFrame: within 2 weeks before surgery and at 3,6 and 12 months postoperatively
measure: Development of chronic pain
timeFrame: at 3,6 and 12 months postoperatively
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht UMC
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: M. A Marcus, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Medical Center
name: J. van Os, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: