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

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. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Conditions

Breast Cancer

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Study Overview

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Study Details

Study overview

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.

Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Commack (Consent and follow-up only), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Consent and follow-up only), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Consent and follow-up only), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Laurie Kirstein, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-11