Prediction of Pain After Breast Cancer Surgery With EEG

EEG as a Predictor for Postoperative Pain and the Development of Chronic Postsurgical Pain After Breast Cancer Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer; Chronic Pain; Postoperative Pain

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Maastricht, Limburg, Netherlands, 6200 MD
      • Maastricht UMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

One hundred and fifty female patients undergoing elective breast cancer surgery in day-case surgery.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute postoperative pain	VAS measured in a daily pain diary	during 4 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Quality of Life measured with SF-36	within 2 weeks before surgery and at 3,6 and 12 months postoperatively
Development of chronic pain	Brief Pain Inventory	at 3,6 and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: M. A Marcus, Prof. Dr., Maastricht University Medical Center; Principal Investigator: J. van Os, Prof. Dr., Maastricht University Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2013
• Last Update Submitted That Met QC Criteria: November 26, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: chronic pain; EEG; acute postoperative pain; prediction; breast cancer surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Breast Diseases; Pain, Postoperative; Breast Neoplasms; Chronic Pain
• Other Study ID Numbers: NL34275.068.11 / MEC 11-2-006