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Active, not recruitingNCT03351348Updated Aug 4, 2026

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

A Phase 3 interventional study of Bupivacaine and patient-reported pain scores in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 22 studies testing bupivacaine in Breast Neoplasms — none open to participants now, 1 under way, 1 of them phase 3. Bupivacaine · Breast Neoplasms.

Planned enrollment
Largest of 22
165 · median 60
Started
2017
with 3 others
Phase 3
3 of 22
none open now
Registered
10th of 22
by date

Among the 22 studies testing bupivacaine in Breast Neoplasms, this one has the largest planned enrollment, is one of 4 that started in 2017, is one of 3 in phase 3, and was the 10th registered.

By phase

22 studies; the count open now beside each. This study's row is marked.

Phase 29 · 0 open
No phase6 · 0 open
Phase 3this study3 · 0 open
Phase 42 · 0 open
Phase 11 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2003; this study’s year is marked. 4 started in 2017.

Size and results

Median enrollment 60 across the 22 interventional studies. Of the 15 that completed or were terminated, 6 (40%) have results posted.

Download CSVWith an account: the 22 studies testing bupivacaine in Breast Neoplasms as a file.
02

Study 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.

03

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Bupivacaine
  • Mastectomy
  • Sentinel lymph node biopsy SLNB
  • 17-576
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
165 participants (estimated)

Study arms

  • Active comparator
    Saline + usual post-operative medications

    The intervention in this study is the insertion of 20cc of saline 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 · Other: saline

  • Experimental
    Bupivacaine + usual post-operative medications

    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.

    Drug: Bupivacaine · Behavioral: patient-reported pain scores

Interventions

  • 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.

  • Behavioralpatient-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).

  • Othersaline

    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.

06

What researchers measure

Primary outcomes

  1. number 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

07

Study locations

7 sites
  • 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)
    East White Plains, 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03351348
Responsible party
Sponsor
First posted
Nov 22, 2017
Start date
Nov 16, 2017
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Aug 4, 2026

Study contacts

Laurie Kirstein, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bupivacaine

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