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NCT03351348PHASE3Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

11/16/2017

Completion Date

11/1/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Bupivacaine

BEHAVIORAL

patient-reported pain scores

OTHER

saline

Interested in This Trial?

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Conditions

Breast Cancer

Locations

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

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey 07748

United States

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

Montvale, New Jersey 07645

United States

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

Commack, New York 11725

United States

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

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

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

Uniondale, New York 11553

United States