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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer

Treatments: Behavioral: patient-reported pain scores; Other: saline; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03351348

17-576

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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165 participants in 2 patient groups

Saline + usual post-operative medications

Active Comparator group

Description:

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.

Treatment:

Other: saline

Behavioral: patient-reported pain scores

Bupivacaine + usual post-operative medications

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine

Behavioral: patient-reported pain scores