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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: patient-reported pain scores; Other: saline; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Estimated): 165
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Laurie Kirstein, MD; Phone Number: 848-225-6121; Email: kirsteil@mskcc.org
• Study Contact Backup: Name: Leslie Sarraf, MD; Phone Number: 212-639-8415

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (All Protocol Activities)
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Consent and follow-up only)
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Commack (Consent and follow-up only)
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Consent and follow-up only)
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Leslie Sarraf, MD; Phone Number: 212-639-8415
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121
      • Principal Investigator: Laurie Kirstein, MD
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
      • Contact: Laurie Kirstein, MD; Phone Number: 848-225-6121

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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).; Other: saline; 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.
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.	Behavioral: patient-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).; Drug: Bupivacaine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Laurie Kirstein, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 22, 2017

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Bupivacaine; Mastectomy; Sentinel lymph node biopsy SLNB; 17-576
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Organic Chemicals; Pharmaceutical Preparations; Anilides; Amides; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Bupivacaine; Saline Solution
• Other Study ID Numbers: 17-576

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No