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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
165
The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).
The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, United States
RECRUITINGMemorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, United States
RECRUITINGMemorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGMemorial Sloan Kettering Nassau (Consent and follow-up only)
Uniondale, New York, United States
RECRUITINGnumber of patients that have moderate to severe pain
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
Time frame: up to 24 hours
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