Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control (NCT03351348) | Clinical Trial Compass
RecruitingPhase 3
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
United States165 participantsStarted 2017-11-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of patients that have moderate to severe pain