Prediction of Pain After Breast Cancer Surgery With EEG

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01392248
• Other study ID #: NL34275.068.11 / MEC 11-2-006
• Status: Terminated
• Phase: N/A
• First received: June 1, 2011
• Last updated: November 26, 2013
• Start date: July 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain
• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Netherlands	Maastricht UMC	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute postoperative pain	VAS measured in a daily pain diary	during 4 days after surgery	No
Secondary	Quality of Life	Quality of Life measured with SF-36	within 2 weeks before surgery and at 3,6 and 12 months postoperatively	No
Secondary	Development of chronic pain	Brief Pain Inventory	at 3,6 and 12 months postoperatively	No