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NCT Number: NCT03351348

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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.

patient-reported pain scores

Behavioral

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).

Saline

Other

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.

Primary outcomes

  1. number of patients that have moderate to severe pain

    Time frame: up to 24 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Laurie Kirstein, MD

CONTACT

[email protected]

848-225-6121

Leslie Sarraf, MD

CONTACT

212-639-8415

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2017
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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