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Could a common numbing drug stop chronic pain after breast surgery?

NCT ID NCT05072314

Symptom relief Sponsor: Monash University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This large phase 3 trial is testing whether giving lidocaine (a numbing medicine) during and after breast cancer surgery can reduce the chance of long-term pain. About 4,300 women having mastectomy or breast-conserving surgery will receive either lidocaine or a placebo. The main goal is to see if fewer women have moderate or severe pain one year later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lidocaine
What this could lead to
If it works, this could provide a simple, low-cost way to prevent chronic pain after breast cancer surgery.
What could go wrong
This is a large trial, but lidocaine is already used for short-term pain; its long-term benefit is unproven. Results may show no difference from placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 4,300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)\*. \* this specifically excludes patients undergoing surgery for locoregional recurrence * American Society of Anaesthesiologist (ASA) physical scale 1-3 Exclusion Criteria: * Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy * Where surgery is being performed for locoregional recurrence of breast cancer * Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures) * Re-excision procedures where the margins at the index surgery have been deemed insufficient * When immediate autologous reconstruction surgery is planned * Where delayed autologous reconstruction surgery on the operative breast within one year is planned * Planned use of regional analgesia infusions * Impaired cognition * Pregnant or lactating females * Transgender patients * Known metastatic disease * History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia * History of epilepsy * Baseline heart rate \< 50 bpm or systolic blood pressure \< 100mmHg. * Acute coronary event in the last three months * Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated * Abnormal serum potassium concentration (based upon site laboratory reference ranges) * Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes) * Medications within the last 7 days which are known / suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs) * Cardiac Failure (any documented heart failure at peroperative assessment or GP records) * Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent) * Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Breast cancer female Breast conserving surgery Mastectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anaesthetic Group Ballarat

    TERMINATED

    Ballarat, Victoria, 3350, Australia

  • Auckland City Hospital

    RECRUITING

    Auckland, Auckland, 1023, New Zealand

  • Ballarat Health Services (Grampians Health)

    RECRUITING

    Ballarat, Victoria, 3350, Australia

  • Barwon Health - University Hospital Geelong

    RECRUITING

    Geelong, Victoria, 3220, Australia

  • Belfast City Hospital

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Bentley Health Service

    RECRUITING

    Bentley, Western Australia, 6102, Australia

  • Blacktown Mount Druitt Hospital

    RECRUITING

    Mount Druitt, New South Wales, 2770, Australia

  • Darlington Memorial Hospital

    TERMINATED

    Darlington, DL3 6HX, United Kingdom

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, South Australia, 5042, Australia

  • Gold Coast Hospital and Health Service- Gold Coast University Hospital

    TERMINATED

    Southport, Queensland, 4215, Australia

  • Goulburn Valley Health

    TERMINATED

    Shepparton, Victoria, 3630, Australia

  • Latrobe Regional Hospital

    WITHDRAWN

    Traralgon, Victoria, 3844, Australia

  • Mackay Base Hospital

    RECRUITING

    Mackay, Queensland, 4740, Australia

  • Maroondah Hospital - Eastern Health

    RECRUITING

    Ringwood East, Victoria, 3135, Australia

  • Middlemore Hospital

    RECRUITING

    Auckland, Middlemore, 2025, New Zealand

  • Monash Health - Moorabbin Hospital

    TERMINATED

    Melbourne, Victoria, 3165, Australia

  • Nepean Hospital

    RECRUITING

    Kingswood, New South Wales, 2747, Australia

  • Newcastle upon Tyne Hospitals

    RECRUITING

    Newcastle upon Tyne, United Kingdom

  • Norfolk and Norwich University Hospital

    RECRUITING

    Norwich, NR4 7UY, United Kingdom

  • North District Hospital

    RECRUITING

    Shatin, Sha Tin, Hong Kong

  • Northern Hospital

    WITHDRAWN

    Melbourne, Victoria, 3076, Australia

  • Pamela Youde Nethersole Eastern Hospital

    RECRUITING

    Chai Wan, Hong Kong

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth II Jubilee Hospital

    RECRUITING

    Coopers Plains, Queensland, 4108, Australia

  • Rockhampton Hospital

    TERMINATED

    Rockhampton, Queensland, 4700, Australia

  • Rotherham NHS Foundation Trust

    RECRUITING

    Rotherham, S60 2UD, United Kingdom

  • Royal Brisbane and Women's Hospital

    TERMINATED

    Brisbane, Queensland, 4029, Australia

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • Royal Hampshire County Hospital

    RECRUITING

    Winchester, SO22 5DG, United Kingdom

  • Royal Hobart Hospital

    RECRUITING

    Hobart, Tasmania, 7000, Australia

  • Royal Liverpool and Broadgreen Hospitals

    RECRUITING

    Liverpool, United Kingdom

  • Royal Marsden Hospital - London and Sutton

    RECRUITING

    London, United Kingdom

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, 3050, Australia

  • Royal North Shore Hospital

    RECRUITING

    Sydney, New South Wales, 2035, Australia

  • Royal Perth Hospital

    RECRUITING

    Perth, Western Australia, 6000, Australia

  • Russells Hall Hospital

    RECRUITING

    Dudley, DY1 2HQ, United Kingdom

  • Ruttonjee Hospital

    RECRUITING

    Wan Chai, Hong Kong

  • Southmead Hospital, North Bristol Trust

    RECRUITING

    Bristol, BS10 5NB, United Kingdom

  • St George Hospital

    RECRUITING

    Sydney, New South Wales, 2217, Australia

  • St Helen's Hospital

    RECRUITING

    St Helens, WA9 3DA, United Kingdom

  • St John of God Subiaco

    RECRUITING

    Perth, Western Australia, 6008, Australia

  • St Vincent's Hospital Melbourne

    RECRUITING

    Melbourne, Victoria, 3065, Australia

  • The Alfred

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • Torbay Hospital

    ACTIVE_NOT_RECRUITING

    Torquay, TQ2 7AA, United Kingdom

  • University Hospital Southampton

    RECRUITING

    Southampton, United Kingdom

  • University Hospital Wishaw

    RECRUITING

    Wishaw, Scotland, United Kingdom

  • Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, 3204, New Zealand

  • Westmead Hospital

    RECRUITING

    Sydney, New South Wales, 2145, Australia

  • Whittington Hospital

    RECRUITING

    London, N19 5NF, United Kingdom

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