RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-11-16
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03351348

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients ≥ 18 years of age
  2. * Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection
  3. * Patients scheduled for surgery at the JRSC or MSK Monmouth
  4. * Previously enrolled patients \> 6 months from contralateral mastectomy
  1. * Patients who are non-English speaking
  2. * Patients having any immediate breast reconstructive procedure
  3. * Patients are having bilateral mastectomy
  4. * Patients who report a baseline pain score \> 3, unrelated to a breast procedure
  5. * Patients who take long acting opioid medication use
  6. * Patients will be excluded if they are having their mastectomy performed with tumescence
  7. * Patients weighing \< 40kg as 20cc of bupivacaine 0.5% is greater than the maximum allowed dose
  8. * Patients within 6 months of previous enrollment for surgery for contralateral mastectomy

Contacts and Locations

Study Contact

Laurie Kirstein, MD
CONTACT
848-225-6121
kirsteil@mskcc.org
Leslie Sarraf, MD
CONTACT
212-639-8415

Principal Investigator

Laurie Kirstein, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (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
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)
Harrison, 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

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-11-16
Study Completion Date2026-11

Study Record Updates

Study Start Date2017-11-16
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Breast Cancer