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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT03216187
• Date of registration: 10/07/2017
• Prospective Registration: Yes
• Primary sponsor: Benno Rehberg-Klug
• Public title: Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery PREVENT
• Scientific title: Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery
• Date of first enrolment: January 9, 2018
• Target sample size: 300
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03216187
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Marc Suter, MD
• Affiliation: CHUV

• Name: Benno Rehberg-Klug, MD

• Name: Benno Rehberg-Klug, MD
• Affiliation: HUG

• Name: Ulrike Stamer, MD
• Affiliation: Inselspital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Persistent Postoperative Pain

Intervention(s)

Drug: Placebos

Drug: Pregabalin

Primary Outcome(s)

incidence of "clinically important pain" at 3 months after surgery [Time Frame: 3 months]

Secondary Outcome(s)

Expectations about treatment benefits before treatment and after [Time Frame: 10 days]

acute pain intensity and patient-reported pain outcome at 24h [Time Frame: 24 hours]

Patient-reported acceptance of the preventive treatment [Time Frame: 3 months]

Pregabalin-related side effects [Time Frame: 10 days]

patient-reported relevance of pain [Time Frame: 3, 6, and 12 months]

retention rates of pregabalin treatment [Time Frame: 30 days]

neuropathic pain [Time Frame: 3, 6, and 12 months]

pain intensity at rest and movement, pain interference [Time Frame: 3, 6, and 12 months]

Secondary ID(s)

PREVENT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centre Hospitalier Universitaire Vaudois

University Hospital, Geneva

University Hospital Inselspital, Berne