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Bupivacaine for Post-operative Pain After Breast Cancer Surgery

Phase 3

Recruiting

Led By Laurie Kirstein, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for surgery at the JRSC or MSK Monmouth

Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection

Must not have

Patients are having bilateral mastectomy

Male breast cancer patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether adding bupivacaine to the surgical site can better manage pain and reduce the amount of opioids needed after surgery.

Who is the study for?

This trial is for women over 18 years old undergoing a unilateral mastectomy, with or without lymph node removal. It's open to those having surgery at specific centers and who haven't had the opposite breast removed within the last 6 months. Excluded are men, bilateral mastectomy patients, long-term opioid users, those under 40kg, non-English speakers, immediate reconstruction cases, and anyone with significant baseline pain.

What is being tested?

The study tests if adding bupivacaine—a numbing medication—directly to the surgical site can better manage post-surgery pain compared to usual painkillers alone. The goal is also to see if this method reduces opioid use after surgery. Participants will either receive bupivacaine or saline (placebo) alongside standard care.

What are the potential side effects?

Bupivacaine may cause side effects like numbness beyond the target area, weakness, nausea or vomiting. In rare cases it could lead to more serious issues such as heart problems or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery at JRSC or MSK Monmouth.

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I am having or had a mastectomy on one breast, with or without lymph node removal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am having both of my breasts removed.

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I am a male diagnosed with breast cancer.

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I experience pain greater than 3 not related to breast surgery.

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I am not having my mastectomy with tumescence.

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I use long-acting opioid medications.

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I weigh less than 40kg.

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I am having immediate breast reconstruction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of patients that have moderate to severe pain

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bupivacaine + usual post-operative medicationsExperimental Treatment2 Interventions

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.

Group II: Saline + usual post-operative medicationsActive Control2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

2013

Completed Phase 4

~1530

0 / 9Eligibility criteria met