Prediction of Pain After Breast Cancer Surgery With EEG

This study has been terminated.
(funding and recruiting problems)
Sponsor:
Information provided by (Responsible Party):
Carine Vossen, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01392248
First received: June 1, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose
  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.

Condition
Breast Cancer
Postoperative Pain
Chronic Pain

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Acute postoperative pain [ Time Frame: during 4 days after surgery ] [ Designated as safety issue: No ]
    VAS measured in a daily pain diary


Secondary Outcome Measures:
  • 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


Enrollment: 4
Study Start Date: July 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392248

Locations
Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands, 6200 MD
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Carine Vossen, MD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01392248     History of Changes
Other Study ID Numbers: NL34275.068.11 / MEC 11-2-006
Study First Received: June 1, 2011
Last Updated: November 26, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
EEG
breast cancer surgery
prediction
acute postoperative pain
chronic pain

Additional relevant MeSH terms:
Chronic Pain
Pain, Postoperative
Breast Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014