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

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

Recruiting
18 years and older
Female
Phase 3

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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.

Eligibility

Inclusion Criteria:

  • Females ≥ 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:

  • Male breast cancer patients
  • 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 details
    Breast Cancer

NCT03351348

Memorial Sloan Kettering Cancer Center

25 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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