Prediction of Pain After Breast Cancer Surgery With EEG

NCT01392248 | Terminated

• 1 other identifier: NL34275.068.11 / MEC 11-2-006
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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.
3. 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.

Conditions

Breast Cancer; Postoperative Pain; Chronic Pain

Keywords

EEG; breast cancer surgery; prediction; acute postoperative pain; chronic pain

Outcome Measures

Primary Outcomes (1)

• Acute postoperative pain

  VAS measured in a daily pain diary

  during 4 days after surgery

Secondary Outcomes (2)

• Quality of Life

  within 2 weeks before surgery and at 3,6 and 12 months postoperatively

• Development of chronic pain

  at 3,6 and 12 months postoperatively

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Chronic Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• M. A Marcus, Prof. Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• J. van Os, Prof. Dr.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: July 12, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: November 28, 2013

Record last verified: 2013-11

Locations

NL (1)