postoperatieve pijn (acuut en chronisch) na borstkanker chirurgie postoperative pain (acute&chronic) after breast cancer surgery
Conditions
Interventions
None listed
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion 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 surgery • Stage I and II breast cancer.
Exclusion criteria
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 of 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 visus 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. • Previous breast surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters/endpoint 1. EEG parameters Firstly, we will try to demonstrate a (predictive) relationship between baseline EEG measures (obtained before the five experimental tasks) and acute postoperative pain and CPSP (as measured at six months follow-up). Secondly, similar predictive relationships are to be determined between EEG/ERP outcome parameters of the five *vulnerability* experiments and acute postoperative pain and CPSP. 2. Pain Intensity During the acute postoperative phase is measured by NRS scales assessing average pain, pain in rest and during movement, and pain at that very moment at a fixed time each day, starting at the day of the operation until 7 days after the operation. Also the DN4 questionnaire is used, a short instrument to assess the neuropathic aspects of pain39. 3. Pain intensity at 3, 6 and 12 months postoperatively: This is assessed by the Brief pain inventory-short form (BPI-SF). It is a 12 item questionnaire which measures pain during the past 24 hours. The BPI-SF has two subscales: pain severity and pain interference. The questionnaire is validated for the Dutch language and is widely used for postoperative pain and pain in cancer patients40. The scale is slightly adapted to specifically refer to pain associated with the surgical procedure. This adaptation is adopted from the study, being conducted by Prof M. Peters, called *Recovery after hysterectomy: A multicentre study into influencing factors which has started recently in our hospital. In our questionnaire we specifically ask for pain in the region of the breast in the postoperative period. The neuropathic character of pain is measured with the DN4. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical functioning will be measured with the physical functioning subscale of the SF36. This subscale consists of 10 items assessing perceived difficulties in physical activities (walking, climbing stairs. etc.). Self-perceived recovery is assessed with the Global Surgical Recovery Scale (GSR). The GSR consist of one item on which patients score how much they feel themselves recovered (0 - 100%). This scale is used previously as an outcome measure in a surgical cohort study in our hospital. | — |
Countries
Netherlands
Outcome results
None listed