Persistent Postoperative PainPhase 3PREVENTNCT03216187
Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery
A Phase 3 study testing Pregabalin in people with Persistent Postoperative Pain, run by Benno Rehberg-Klug at 6 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Persistent Postoperative Pain
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 6 sitesSwitzerland
- Study dates
- 9 Jan 2018to 29 Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Switzerland6 sites
Inselspital
Bern, 3010
Brustzentrum Bern
Bern
Hôpitaux Universitaires de Genève HUG
Geneva, 1211
Clinique des Grangettes
Geneva
Clinique de Genolier
Genolier, 1272
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, 1011
About this study
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.
Read the detailed description
BACKGROUND Persistent postsurgical pain occurs in more than 30% of patients undergoing breast cancer surgery. Evidence that gabapentinoids such as pregabalin may reduce the incidence of persistent postsurgical pain is ambiguous, potentially because in previous trials prophylactic treatment was administered to every patient undergoing surgery. The patients at low risk of long term pain, were exposed to side effects without much benefit to expect.
AIM Validating or refuting the utility of pregabalin to prevent long term post-operative pain in patients at high risk of persistent pain after breast cancer surgery.
METHODS Randomized, double-blind, placebo-controlled trial of pregabalin (2*150mg from the day before breast cancer surgery until 2 weeks after surgery) in patients at high risk of persistent pain (>30%). High-risk patients are identified by a risk score derived from a previous observational study. The main outcome is the incidence of clinically important pain (necessitating analgesic treatment, or having an intensity of >3 at rest or >5 on movement) at 3 months after surgery. Secondary outcomes are: incidence of neuropathic pain, pain interference, and incidences at 6 and 12 months of follow-up. In addition, side effects of pregabalin and the retention rate during the treatment period will be monitored, as well as patient expectancies.
RELEVANCE This is the first study for prevention of persistent postoperative pain which targets only high-risk patients, thus lowering a false negative outcome and averting the risk of side effects for patients at low risk.
The study is powered to show a reduction of the incidence of clinically important pain at 3 months of 20%. In the case the study shows that this can be achieved and pregabalin is well tolerated, the preventive use of pregabalin for breast cancer surgery would be justified at least in high-risk patients. On the other hand, a negative result would indicate the futility of pregabalin prevention, which is already in routine use in many hospitals.
- Conditions
- Persistent Postoperative Pain
- Being tested
- Pregabalin, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Also called Pregabalin 150mg capsules
pregabalin 150 mg capsules
PlacebosDrug
Also called placebo capsules
capsules identical to pregabalin but without active drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (8)
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
Measured: 10 days
retention rates of pregabalin treatment
Measured: 30 days
acute pain intensity and patient-reported pain outcome at 24h
PAIN-OUT questionnaire
Measured: 24 hours
pain intensity at rest and movement, pain interference
Brief Pain Inventory, BPI
Measured: 3, 6, and 12 months
neuropathic pain
incidence of neuropathic pain defined as a DN4-self-evaluation score ≥4
Measured: 3, 6, and 12 months
patient-reported relevance of pain
response to the question: "do you consider your pain as significant?"
Measured: 3, 6, and 12 months
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?")
Measured: 3 months
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?")
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start9 Jan 2018
- Primary completion11 Jun 2024
- Study completion29 Nov 2024
Why it stopped: insufficient funding and recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded, randomized, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benno Rehberg-Klug
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor-investigator, Benno Rehberg-Klug, University Hospital, Geneva
- Investigators
- Benno Rehberg-Klug, MD, Study director, HUGMarc Suter, MD, Study director, CHUVUlrike Stamer, MD, Study director, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216187
- Sponsor's protocol ID
- PREVENT
- Acronym
- PREVENT
- Status last verified
- Oct 2025
- First submitted
- 10 Jul 2017
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03216187
- Acronym / sponsor ID
- PREVENT / PREVENT
- Conditions
- Persistent Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient funding and recruitment
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Benno Rehberg-KlugUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND Persistent postsurgical pain occurs in more than 30% of patients undergoing breast cancer surgery. Evidence that gabapentinoids such as pregabalin may reduce the incidence of persistent postsurgical pain is ambiguous, potentially because in previous trials prophylactic treatment was administered to every patient undergoing surgery. The patients at low risk of long term pain, were exposed to side effects without much benefit to expect.
AIM Validating or refuting the utility of pregabalin to prevent long term post-operative pain in patients at high risk of persistent pain after breast cancer surgery.
METHODS Randomized, double-blind, placebo-controlled trial of pregabalin (2*150mg from the day before breast cancer surgery until 2 weeks after surgery) in patients at high risk of persistent pain (>30%). High-risk patients are identified by a risk score derived from a previous observational study. The main outcome is the incidence of clinically important pain (necessitating analgesic treatment, or having an intensity of >3 at rest or >5 on movement) at 3 months after surgery. Secondary outcomes are: incidence of neuropathic pain, pain interference, and incidences at 6 and 12 months of follow-up. In addition, side effects of pregabalin and the retention rate during the treatment period will be monitored, as well as patient expectancies.
RELEVANCE This is the first study for prevention of persistent postoperative pain which targets only high-risk patients, thus lowering a false negative outcome and averting the risk of side effects for patients at low risk.
The study is powered to show a reduction of the incidence of clinically important pain at 3 months of 20%. In the case the study shows that this can be achieved and pregabalin is well tolerated, the preventive use of pregabalin for breast cancer surgery would be justified at least in high-risk patients. On the other hand, a negative result would indicate the futility of pregabalin prevention, which is already in routine use in many hospitals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blinded, randomized, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: PregabalinPregabalin 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 | Placebo comparator | Drug: PlacebosIdentical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PregabalinAlso: Pregabalin 150mg capsulespregabalin 150 mg capsules | Drug | Pregabalin |
| PlacebosAlso: placebo capsulescapsules identical to pregabalin but without active drug | Drug | Placebo |
Primary outcome
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.
8 secondary outcomes
Pregabalin-related side effects
Time frame: 10 days
retention rates of pregabalin treatment
Time frame: 30 days
acute pain intensity and patient-reported pain outcome at 24h
Time frame: 24 hours
pain intensity at rest and movement, pain interference
Time frame: 3, 6, and 12 months
neuropathic pain
Time frame: 3, 6, and 12 months
patient-reported relevance of pain
Time frame: 3, 6, and 12 months
Patient-reported acceptance of the preventive treatment
Time frame: 3 months
Expectations about treatment benefits before treatment and after
Time frame: 10 days
Results and safety
The study was stopped early (reason given: insufficient funding and recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benno Rehberg-Klug, MD study director
HUG
Marc Suter, MD study director
CHUV
Ulrike Stamer, MD study director
Inselspital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pregabalin in people with Persistent Postoperative Pain, run by Benno Rehberg-Klug at 6 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient funding and recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of "clinically important pain" at 3 months after surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.