Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery
1. incidence of "clinically important pain" at 3 months after surgery (Time Frame - 3 months): "Clinically important pain" is defined by: taking analgesics for pain at the surgical site OR average resting pain at the surgical site >3/10 OR average movement-induced pain at the surgical site >5/10.
Secondary outcome:
1. Pregabalin-related side effects (Time Frame - 10 days): blurred vision or diplopia, somnolence or sleepiness, abnormal thinking, confusional state, disturbed attention, and falls, as well as the effects noted in the "generic assessment of side effects" GASE questionnaire
3. acute pain intensity and patient-reported pain outcome at 24h (Time Frame - 24 hours): PAIN-OUT questionnaire
4. pain intensity at rest and movement, pain interference (Time Frame - 3, 6, and 12 months): Brief Pain Inventory, BPI
5. neuropathic pain (Time Frame - 3, 6, and 12 months): incidence of neuropathic pain defined as a DN4-self-evaluation score ≥4
6. patient-reported relevance of pain (Time Frame - 3, 6, and 12 months): response to the question: "do you consider your pain as significant?"
7. Patient-reported acceptance of the preventive treatment (Time Frame - 3 months): response to the question "In retrospect, do you consider the preventive treatment worthwhile, given your pain outcome and your experience of taking the medication?")
8. Expectations about treatment benefits before treatment and after (Time Frame - 10 days): responses to the questions: "How much pain do you expect 3 months from now?"" "How efficient do you think the study treatment is against the long-term pain (i.e. what is the success rate in %)?" "How well do you think it will work for you? (i.e. reduction in pain score 0-10)". Beliefs about treatment attribution after 10 days of treatment (question: "Do you think that you received the real drug or the placebo?")
Experimental: Pregabalin Pregabalin 150 mg twice daily, starting from the evening before surgery, continuing with two times 150mg per day for 12 days, and ending with one 150mg capsule every evening for the final 3 days.
Placebo Comparator: Placebo Identical placebo capsules twice daily, starting from the evening before surgery, continuing with two capsules per day for 12 days, and ending with one capsule every evening for the final 3 days.
Placebos (placebo capsules): capsules identical to pregabalin but without active drug
Quelle: ClinicalTrials.gov
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