Actively Recruiting
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-08-26
165
Participants Needed
7
Research Sites
467 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Patients undergoing unilateral mastectomy with or without sentinel lymph node biopsy or axillary dissection
- Patients scheduled for surgery at the JRSC or MSK Monmouth
- Previously enrolled patients more than 6 months from contralateral mastectomy
You will not qualify if you...
- Patients who do not speak English
- Patients having any immediate breast reconstructive procedure
- Patients undergoing bilateral mastectomy
- Patients with a baseline pain score greater than 3 unrelated to breast procedures
- Patients who use long-acting opioid medications
- Patients having mastectomy performed with tumescence
- Patients weighing less than 40 kg
- Patients within 6 months of previous enrollment for contralateral mastectomy surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Consent and follow-up only)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
L
Laurie Kirstein, MD
CONTACT
L
Leslie Sarraf, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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