Can a numbing wash cut opioid use after breast surgery?
NCT ID NCT03351348
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 165 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2017
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Consent and follow-up only)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester (Consent and follow-up only)
East White Plains, New York, 10604, United States
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Other studies related to the condition(s) this trial covers.
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