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Bupivacaine for Post-Mastectomy Pain Control

This study is looking at whether adding bupivacaine (a numbing medicine) directly into the surgical wound after a unilateral mastectomy (removal of one breast) can better control pain and reduce the need for opioid pain medications. You may be able to join if you are an adult woman (18 years or older) having a unilateral mastectomy at JRSC or MSK Monmouth, with or without lymph node removal. The study aims to find out if this approach leads to fewer patients experiencing moderate to severe pain within 24 hours after surgery. The current status of this study is unclear, and it plans to enroll 165 participants.

Study design
This interventional study plans to enroll 165 participants. It compares bupivacaine to saline (saltwater) given through a drain in the wound.
What's involved
You would receive either bupivacaine or saline through a drain in your mastectomy wound for about 2 hours after surgery. Your pain scores will be recorded by a nurse, and you will complete a pain questionnaire 6 months and 1 year after surgery.
Compensation
Not stated in the trial record.
Follow-up
Your pain levels will be assessed for up to 24 hours after surgery, and you will complete follow-up pain questionnaires 6 months and 1 year after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03351348

Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~165 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Bupivacainepatient-reported pain scoressaline

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
number of patients that have moderate to severe pain
Measured over up to 24 hours

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Laurie Kirstein, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • number of patients that have moderate to severe painup to 24 hours

    Validated measures consisting of the Comparative Pain Scale and Simplified Postoperative Nausea and Vomiting (PONV) impact scale are currently administered to postoperative patients at JRSC. The Comparative pain scale ranges from 0-10, with 0 representing no pain and 10 representing the most severe pain. 0 = no pain 1-3 = minor pain 4-6 = moderate pain 7-10 = severe pain