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

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Patient-Reported Pain Scores
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral, Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Consent and follow-up only)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack (Consent and follow-up only)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Consent and follow-up only)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Memorial Sloan Kettering Nassau (Consent and follow-up only)
RECRUITING
Uniondale
Contact Information
Primary
Laurie Kirstein, MD
kirsteil@mskcc.org
848-225-6121
Backup
Leslie Sarraf, MD
212-639-8415
Time Frame
Start Date: 2017-11-16
Estimated Completion Date: 2026-11
Participants
Target number of participants: 165
Treatments
Active_comparator: Saline + usual post-operative medications
The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.
Experimental: Bupivacaine + usual post-operative medications
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.
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov