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

Status:	Recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/28/2018
Start Date:	November 16, 2017
End Date:	November 2020
Contact:	Laurie Kirstein, MD
Email:	kirsteil@mskcc.org
Phone:	848-225-6121

Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction

The purpose of this study is to compare using bupivacaine (a numbing medicine) along with the
usual medications for post-operative pain control to using the usual medications for
post-operative pain control alone. The addition of bupivacaine to the usual pain medications
could better manage 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.

Inclusion Criteria:

- Females ≥ 18 years of age

- Patients undergoing unilateral mastectomy with or without SLNB or axillary dissection

- Patients scheduled for surgery at the JRSC

Exclusion Criteria:

- Male breast cancer patients

- Patients who are non-English speaking

- Patients having any immediate 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

We found this trial at

sites

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey 07920

Phone: 848-225-6121

from

Basking Ridge, NJ