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

PHASE3RecruitingINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

November 16, 2017

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Breast Cancer
Interventions
DRUG

Bupivacaine

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.

BEHAVIORAL

patient-reported pain scores

Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).

OTHER

saline

The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Consent and follow-up only), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Consent and follow-up only), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Commack (Consent and follow-up only), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Consent and follow-up only), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER