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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

number of patients that have moderate to severe pain

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,666 Total Patients Enrolled

202 Trials studying Breast Cancer

80,993 Patients Enrolled for Breast Cancer

Laurie Kirstein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT03351348 — Phase 3

Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03351348 — Phase 3

Breast Cancer Research Study Groups: Saline + usual post-operative medications, Bupivacaine + usual post-operative medications

Breast Cancer Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT03351348 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Bupivacaine used to treat?

"Bupivacaine can be used to treat permphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

Has Bupivacaine completed the necessary clinical trials for federal approval?

"Bupivacaine has undergone Phase 3 clinical trials, which provides data supporting its efficacy and safety. Consequently, our team at Power rates it a 3 on our safety scale."

Answered by AI

What is the Bupivacaine research landscape like?

"As of this moment, there are one hundred and twenty-three clinical trials currently underway that are studying bupivacaine. Out of those, twenty are Phase 3 trials. Most of the research is happening in Philadelphia, Pennsylvania, but there are one hundred and sixty-nine different locations running trials for this medication."

Answered by AI

Are there any unfilled slots in this experiment that I could take part in?

"Indeed, the information available on clinicaltrials.gov suggests that this study is still searching for participants. The trial was first posted on November 16th, 2017 and was last updated on March 2nd, 2022. Currently, the study is looking for 144 patients from 9 different locations."

Answered by AI

What is the target recruitment for this clinical trial?

"That is correct. The clinicaltrials.gov website indicates that the trial is currently enrolling patients. The listing was first posted on November 16th, 2017 and was updated as recently as March 2nd, 2022. 9 different medical sites are looking to enroll a total of 144 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03351348.

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