Persistent Postoperative Pain Clinical Trial
— PREVENTOfficial title:
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | January 1, 2026 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Brustzentrum Bern | Bern | |
Switzerland | Inselspital | Bern | |
Switzerland | Clinique des Grangettes | Geneva | |
Switzerland | Hôpitaux Universitaires de Genève HUG | Geneva | |
Switzerland | Clinique de Genolier | Genolier | |
Switzerland | Centre Hospitalier Universitaire Vaudois CHUV | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Benno Rehberg-Klug | Centre Hospitalier Universitaire Vaudois, University Hospital Inselspital, Berne, University Hospital, Geneva |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of "clinically important pain" at 3 months after surgery | "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. | 3 months | |
Secondary | Pregabalin-related side effects | 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 | 10 days | |
Secondary | retention rates of pregabalin treatment | 30 days | ||
Secondary | acute pain intensity and patient-reported pain outcome at 24h | PAIN-OUT questionnaire | 24 hours | |
Secondary | pain intensity at rest and movement, pain interference | Brief Pain Inventory, BPI | 3, 6, and 12 months | |
Secondary | neuropathic pain | incidence of neuropathic pain defined as a DN4-self-evaluation score =4 | 3, 6, and 12 months | |
Secondary | patient-reported relevance of pain | response to the question: "do you consider your pain as significant?" | 3, 6, and 12 months | |
Secondary | Patient-reported acceptance of the preventive treatment | response to the question "In retrospect, do you consider the preventive treatment worthwhile, given your pain outcome and your experience of taking the medication?") | 3 months | |
Secondary | Expectations about treatment benefits before treatment and after | 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?") | 10 days |
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