Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery

Inclusion Criteria:

* patients scheduled for breast surgery for cancer, either breast-conserving (tumorectomy/ quadrantectomy) or mastectomy, with or without immediate reconstruction, and with or without axillary dissection.
* patients of 18 years or more scheduled for above mentioned type of surgery
* ability to speak and read French, English or German
* high (\>30%) risk of clinically important persistent pain: identified with 2 or more points of a risk score including the items: pre-existing pain at surgical site (2 points), history of depression (1 point), age \< 50 years (1 point), and high expected acute pain (\>6/10, 1 point).
* Informed Consent as documented by signature.

Exclusion Criteria:

* Inability to understand the consent form and to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Pregnancy or lactation - Renal insufficiency (creatinine clearance \< 60 ml/min)
* Allergy to pregabalin or the ingredients of the capsules
* Long-term preoperative therapy with gabapentinoids or high-dose opioids (more than 60 mg of morphine equivalents)
* Symptomatic cardiac insufficiency (peripheral oedema, NYHA class III - marked limitation of physical activity)
* Suicidal ideation, identified by the question: "have you been bothered by thoughts that you would be better off dead, or of killing yourself?"
* Planned fertility preservation immediately after surgery before a planned chemotherapy
* Known or suspected non-compliance, or substance-use disorder with impact on medication adherence