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Can a numbing wash cut opioid use after breast surgery?

NCT ID NCT03351348

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests whether adding bupivacaine, a numbing medicine, directly into the surgical wound after a mastectomy can improve pain control and reduce the need for opioid painkillers. Participants receive either bupivacaine or a placebo through a drain placed in the wound, along with standard pain medications. The study tracks pain scores right after surgery and checks for chronic pain at 6 months and 1 year. If successful, this simple addition could make recovery more comfortable and lower opioid use.

What this could mean

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

Active substance
bupivacaine (a numbing medicine) placed into the surgical wound after mastectomy
What this could lead to
If effective, this approach could offer better immediate pain relief after mastectomy and reduce the need for opioid painkillers, potentially lowering the risk of opioid-related side effects and dependence.
What could go wrong
The trial is relatively small and focuses on short-term outcomes; results may not apply to all patients or surgeries. Bupivacaine is generally safe but can cause side effects like numbness, dizziness, or rare allergic reactions.

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 165 people

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

Started

Nov 2017

Expected to finish

Nov 2027

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: * Patients ≥ 18 years of age * Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection * Patients scheduled for surgery at the JRSC or MSK Monmouth * Previously enrolled patients \> 6 months from contralateral mastectomy Exclusion Criteria: * Patients who are non-English speaking * Patients having any immediate breast reconstructive procedure * Patients are having bilateral mastectomy * Patients who report a baseline pain score \> 3, unrelated to a breast procedure * Patients who take long acting opioid medication use * Patients will be excluded if they are having their mastectomy performed with tumescence * Patients weighing \< 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose * Patients within 6 months of previous enrollment for surgery for contralateral mastectomy

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen (Consent and follow-up only)

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack (Consent and follow-up only)

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Consent and follow-up only)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester (Consent and follow-up only)

    East White Plains, New York, 10604, United States

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