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

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Behavioral: patient-reported pain scores; Drug: Bupivacaine; Other: saline

• Registration Number: NCT03351348
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-11-16
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 144

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline + usual post-operative medications	patient-reported pain scores	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.
Bupivacaine + usual post-operative medications	patient-reported pain scores	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.
Saline + usual post-operative medications	saline	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.
Bupivacaine + usual post-operative medications	Bupivacaine	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 Measures

Name	Time	Method
number of patients that have moderate to severe pain	up to 24 hours	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

Trial Locations

Locations (7)

Memorial Sloan Kettering Commack (Consent and follow-up only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Nassau (Consent and follow-up only); 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Westchester (Consent and follow-up only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only); 🇺🇸 Basking Ridge, New Jersey, United States