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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bupivacaine — DRUG
  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.
• patient-reported pain scores — BEHAVIORAL
  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).
• saline — OTHER
  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.

Study Details

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.

Key Dates

Start date

Nov 16, 2017

Status verified

Aug 2025

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

165 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

number of patients that have moderate to severe pain [ Time Frame: up to 24 hours ]

Central Contacts

• Laurie Kirstein, MD
  848-225-6121
  [email protected]
• Leslie Sarraf, MD
  212-639-8415

Locations (7)

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