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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benno Rehberg-Klug
• Collaborators: Centre Hospitalier Universitaire Vaudois; University Hospital Inselspital, Berne; University Hospital, Geneva
• Treatments: Pregabalin

Criteria

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