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

RECRUITINGPhase 3Sponsored by Memorial Sloan Kettering Cancer Center
Actively Recruiting
PhasePhase 3
SponsorMemorial Sloan Kettering Cancer Center
Started2017-11-16
Est. completion2026-11
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations7 sites

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

Locations7 sites

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, 07920
Laurie Kirstein, MD848-225-6121
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Laurie Kirstein, MD848-225-6121
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, 07645
Laurie Kirstein, MD848-225-6121
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, 11725
Laurie Kirstein, MD848-225-6121
Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York, 10604
Laurie Kirstein, MD848-225-6121

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