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
Verified date | June 2024 |
Source | University Hospital, Geneva |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 126 |
Est. completion date | November 29, 2024 |
Est. primary completion date | June 11, 2024 |
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, Insel Gruppe AG, University Hospital Bern, 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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