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

This study will test the benefits and risks of using pregabalin perioperatively to prevent persistent postoperative pain in patients at high risk (\>30%) of developing such pain after 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