NCT03351348

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
5mo left

Started Nov 2017

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Nov 2017Nov 2026

Study Start

First participant enrolled

November 16, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

9 years

First QC Date

November 20, 2017

Last Update Submit

August 25, 2025

Conditions

Breast Cancer

Keywords

BupivacaineMastectomySentinel lymph node biopsy SLNB17-576

Outcome Measures

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

    up to 24 hours

Study Arms (2)

Saline + usual post-operative medications

ACTIVE COMPARATOR

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 scoresOther: saline

Bupivacaine + usual post-operative medications

EXPERIMENTAL

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: BupivacaineBehavioral: patient-reported pain scores

Interventions

BupivacaineDRUG

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.

Bupivacaine + usual post-operative medications
patient-reported pain scoresBEHAVIORAL

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).

Bupivacaine + usual post-operative medicationsSaline + usual post-operative medications
salineOTHER

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.

Saline + usual post-operative medications

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Consent and follow-up only)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack (Consent and follow-up only)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Consent and follow-up only)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Consent and follow-up only)

Uniondale, New York, 11553, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BupivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Laurie Kirstein, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurie Kirstein, MD

CONTACT

848-225-6121kirsteil@mskcc.org

Leslie Sarraf, MD

CONTACT

212-639-8415

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Treatment assignments can be viewed only by the hospital pharmacists who are dispensing the study drugs.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, double-blind, randomized, placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 22, 2017

Study Start

November 16, 2017

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations

US(7)