Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control (NCT03351348)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (9 items).
Location: Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) — Basking Ridge, New Jersey
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (7 Sites)
- Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) — Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Consent and follow-up only) — Montvale, New Jersey
- Memorial Sloan Kettering Commack (Consent and follow-up only) — Commack, New York
- Memorial Sloan Kettering Westchester (Consent and follow-up only) — East White Plains, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- Memorial Sloan Kettering Nassau (Consent and follow-up only) — Uniondale, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.