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

NCT03216187 | Terminated Phase 3 DMC

• 1 other identifier: PREVENT
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Persistent Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Pregabalin-related side effects

  10 days

• retention rates of pregabalin treatment

  30 days

• acute pain intensity and patient-reported pain outcome at 24h

  24 hours

• pain intensity at rest and movement, pain interference

  3, 6, and 12 months

• neuropathic pain

  3, 6, and 12 months

Study Arms (2)

Pregabalin

EXPERIMENTAL

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.

Drug: Pregabalin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebos

Interventions

Pregabalin DRUG

pregabalin 150 mg capsules

Also known as: Pregabalin 150mg capsules

Pregabalin

Placebos DRUG

capsules identical to pregabalin but without active drug

Also known as: placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benno Rehberg-Klug: lead
• University Hospital, Geneva: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (6)

Inselspital

Bern, 3010, Switzerland

Location

Brustzentrum Bern

Bern, Switzerland

Location

Hôpitaux Universitaires de Genève HUG

Geneva, 1211, Switzerland

Location

Clinique des Grangettes

Geneva, Switzerland

Location

Clinique de Genolier

Genolier, 1272, Switzerland

Location

Centre Hospitalier Universitaire Vaudois CHUV

Lausanne, 1011, Switzerland

Location

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Benno Rehberg-Klug, MD

  HUG

  STUDY DIRECTOR

• Marc Suter, MD

  CHUV

  STUDY DIRECTOR

• Ulrike Stamer, MD

  Inselspital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: study drugs (including identical placebos) and randomisation lists are prepared by the hospital pharmacy and are kept secret from the investigators until the end of the study and the "freezing" of the electronic data base (an interim analysis will be performed when data for the primary outcome are available for 60 patients per arm. Stopping rules are a difference in the incidence of the primary outcome of less than 8.2% (futility) or more than 19.9% (superiority)).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: médecin adjoint agrégé

Model Details: double-blinded, randomized, placebo-controlled trial

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: January 9, 2018
• Primary Completion: June 11, 2024
• Study Completion: November 29, 2024
• Last Updated: October 7, 2025

Record last verified: 2025-10

Locations

CH (6)