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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone. The addition of bupivacaine to the surgical wound site with the usual pain medications could better manage your pain immediately after surgery and reduce the amount of opioid medications taken after surgery. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Key facts

Study ID

NCT03351348

Run by

Memorial Sloan Kettering Cancer Center

People needed

165

Starts

2017-11-16

Expected to finish

2027-11-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Consent and follow-up only) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Consent and follow-up only) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Consent and follow-up only) — East White Plains, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Consent and follow-up only) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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