RecruitingPhase 3NCT03351348

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

165 participants

Start Date

Nov 16, 2017

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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 Criteria8

Patients who are non-English speaking
Patients having any immediate breast 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
Patients within 6 months of previous enrollment for surgery for contralateral mastectomy

Interventions

DRUGBupivacaine

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.

BEHAVIORALpatient-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).

OTHERsaline

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.