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Simple drug during surgery may stop chronic pain after breast cancer

NCT ID NCT04874038

Prevention Sponsor: University Health Network, Toronto 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large Phase 3 trial tests whether giving lidocaine (a numbing medicine) through an IV during breast cancer surgery can prevent persistent pain that often follows. Over 1,600 adults having lumpectomy or mastectomy will be randomly assigned to receive lidocaine or a placebo. The main goal is to see if fewer people develop pain 3 months after surgery.

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, safe way to prevent long-term pain after breast cancer surgery.
What could go wrong
This is a large Phase 3 trial, but lidocaine is already widely used; the benefit may be small or not apply to all patients. Pain is complex and may not be fully prevented.

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 1,602 people

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

Started

Sep 2021

Expected to finish

Nov 2026

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 to 100 years

Sex

Anyone

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: 1. Age ≥18 years old 2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation) Exclusion Criteria: 1. Previous breast surgery within 6 months of index surgery 2. Undergoing any autologous flap procedure during index surgery 3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery 4. Documented hypersensitivity or allergy to lidocaine 5. Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block) 6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker 7. Known cirrhotic liver disease 8. Pregnant 9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Chronic Pain chronic pain syndrome Pain, Postoperative

As listed by the trial registrant

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

Breast cancer Pain, chronic Pain, postoperative Post-mastectomy pain syndrome

How to take part

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

  1. The places running it

    17 sites in 3 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

  • B.P. Koirala Institute of Health Sciences

    RECRUITING

    Dharān, Nepal

  • Eastern Health- Health Sciences Centre

    RECRUITING

    St. John's, Newfoundland and Labrador, Canada

  • Foothills Medical Centre

    RECRUITING

    Calgary, Alberta, Canada

  • Humber River Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Hôpital Maisonneuve-Rosemont

    RECRUITING

    Montreal, Quebec, Canada

  • IWK

    RECRUITING

    Halifax, Nova Scotia, Canada

  • Juravinski Hospital

    RECRUITING

    Hamilton, Ontario, Canada

  • Mount Sinai Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • North York General Hospital

    RECRUITING

    North York, Ontario, Canada

  • Obafemi Awolowo University Teaching Hospitals Complex

    RECRUITING

    Ile-Ife, Nigeria

  • St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, Canada

  • Sturgeon Community Hospital

    RECRUITING

    Edmonton, Alberta, Canada

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, Canada

  • Thunder Bay Regional Health Sciences Centre

    RECRUITING

    Thunder Bay, Ontario, Canada

  • University Health Network

    RECRUITING

    Toronto, Ontario, Canada

  • Women's College Hospital

    RECRUITING

    Toronto, Ontario, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.