NCT03351348 · Memorial Sloan Kettering Cancer Center
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Bupivacaine
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.
BEHAVIORAL
patient-reported pain scores
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).
OTHER
saline
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.
Primary outcome measures
number of patients that have moderate to severe pain
Time frame: up to 24 hours
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Basking Ridge, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Uniondale, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 26, 2025 · Source of record for eligibility and locations