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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01392248
Other study ID # NL34275.068.11 / MEC 11-2-006
Secondary ID
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


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
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