Supporting Better Pain Management After Breast Surgery with Bupivacaine
NCT03351348 · RecruitingThis study looks at how well bupivacaine, a numbing medicine, works to control pain after a unilateral mastectomy, which is surgery to remove one breast. Researchers want to see if adding bupivacaine to the usual pain medications helps reduce pain more than just using the usual medications alone. The goal is to better manage pain right after surgery and lessen the need for opioid medications.
Locations and contact
This trial is running at 7 locations in the United States. All of them are currently recruiting.
United States7 locations · 7 recruiting
- Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)Basking Ridge, New JerseyRecruiting
- Memorial Sloan Kettering Bergen (Consent and follow-up only)Montvale, New JerseyRecruiting
- Memorial Sloan Kettering Cancer CenterNew York, New YorkRecruiting
- Memorial Sloan Kettering Commack (Consent and follow-up only)Commack, New YorkRecruiting
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, New JerseyRecruiting
- Memorial Sloan Kettering Nassau (Consent and follow-up only)Uniondale, New YorkRecruiting
- Memorial Sloan Kettering Westchester (Consent and follow-up only)Harrison, New YorkRecruiting
Who can join
This trial is open to women aged 18 and older who are having a unilateral mastectomy without immediate breast reconstruction. It is for patients having surgery at specific locations and those who have not had a previous mastectomy in the last six months. There are some reasons a person might not be able to join, such as being non-English speaking or having certain medical conditions. The trial team will confirm who is eligible.
What happens during the trial
Participants will be randomly placed into two groups. One group will receive 20cc of bupivacaine, while the other group will receive 20cc of saline, both inserted into the surgical area after surgery. Everyone will also receive usual post-operative pain medications. Pain scores will be recorded by nurses and assessed again at 6 months and 1 year after surgery.
The trial team
The trial is sponsored by Memorial Sloan Kettering Cancer Center. Dr. Laurie Kirstein is the principal investigator leading the study.
Important dates
The trial started on November 16, 2017, and is currently recruiting new participants. It is expected to finish in November 2026.
Additional information
The trial ID is NCT03351348. This is a Phase 3 trial, which means it is looking at how well the treatment works and its safety. About 165 people will take part in the trial, and it involves an FDA-regulated drug.
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