Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
Recruiting
Phase 3
Interventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 165 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Other
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About This Trial
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 opioi…
Trial Locations
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Eligibility Criteria
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:
* Pati…
Contacts
Leslie Sarraf, MD
212-639-8415
CONTACT