Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
NCT ID: NCT03351348
Last Updated: 2025-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
165 participants
INTERVENTIONAL
2017-11-16
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
patient-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).
saline
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.
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.
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.
patient-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).
Interventions
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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.
patient-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).
saline
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Laurie Kirstein, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, 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 Nassau (Consent and follow-up only)
Uniondale, New York, United States
Countries
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Central Contacts
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Leslie Sarraf, MD
Role: CONTACT
Facility Contacts
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Laurie Kirstein, MD
Role: primary
Laurie Kirstein, MD
Role: primary
Laurie Kirstein, MD
Role: primary
Laurie Kirstein, MD
Role: primary
Laurie Kirstein, MD
Role: primary
Laurie Kirstein, MD
Role: primary
Leslie Sarraf, MD
Role: backup
Laurie Kirstein, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-576
Identifier Type: -
Identifier Source: org_study_id
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