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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 belowSelect...
I am scheduled for surgery at JRSC or MSK Monmouth.
Select...
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:Select...
I am having both of my breasts removed.
Select...
I am a male diagnosed with breast cancer.
Select...
I experience pain greater than 3 not related to breast surgery.
Select...
I am not having my mastectomy with tumescence.
Select...
I use long-acting opioid medications.
Select...
I weigh less than 40kg.
Select...
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
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,699 Total Patients Enrolled
207 Trials studying Breast Cancer
82,819 Patients Enrolled for Breast Cancer
Laurie Kirstein, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having both of my breasts removed.It's been over 6 months since my other breast was removed.I am a male diagnosed with breast cancer.I experience pain greater than 3 not related to breast surgery.I am not having my mastectomy with tumescence.I am scheduled for surgery at JRSC or MSK Monmouth.I use long-acting opioid medications.I weigh less than 40kg.You cannot speak English.I had surgery for the opposite breast removal within the last 6 months.I am having or had a mastectomy on one breast, with or without lymph node removal.I am a woman aged 18 or older.I am having immediate breast reconstruction.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Saline + usual post-operative medications
- Group 2: Bupivacaine + usual post-operative medications
Awards:
This trial has 2 awards, including:- 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.