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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Bupivacaine
* Behavioral: patient-reported pain scores
* Other: saline


Participation Criteria
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Eligibility Criteria
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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 or MSK Monmouth Previously enrolled patients > 6 months from contralateral mastectomy Exclusion Criteria: Male breast cancer patients 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, double-blind, randomized, placebo-controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saline + usual post-operative medications<br>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. | Behavioral: patient-reported pain scores<br>* 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).<br>Other: saline<br>* 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.<br>|
| Experimental: Bupivacaine + usual post-operative medications<br>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. | Drug: Bupivacaine<br>* 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.<br>Behavioral: patient-reported pain scores<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients that have moderate to severe pain | Validated measures consisting of the Comparative Pain Scale and Simplified Postoperative Nausea and Vomiting (PONV) impact scale are currently administered to postoperative patients at JRSC. The Comparative pain scale ranges from 0-10, with 0 representing no pain and 10 representing the most severe pain. 0 = no pain 1-3 = minor pain 4-6 = moderate pain 7-10 = severe pain | up to 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Mastectomy, Sentinel lymph node biopsy SLNB, 17-576