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

StatusActive, Not Recruiting
PhasePhase 3
Started2017-11-16
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Nov 2026 → Nov 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-08-03
Study Status, Contacts/Locations v16
Enrollment closed, study ongoing
Primary completion pushed: 2026-11 → 2027-11
Completion pushed: 2026-11 → 2027-11
Study sitesdetails revised at 7 of 7 sites
2025-08-25
Study Status, Study Design, Contacts/Locations v15
Enrollment target144→165
Study sites7 entries, revised
Memorial Sloan Kettering Bergen (Consent and follow-up only)
2024-12-04
Study Status, Eligibility v14
Eligibility criteria-27 characters
Inclusion Criteria: FemalesPatients ≥ 18 years of age Patients undergoing unilateral mastectomy [...] 6 months from contralateral mastectomy Exclusion Criteria: Male breast cancer patients Patients who are non-English speaking Patients having any im [...]
2023-12-12
Study Status v13
Re-verified, no change to tracked fields
2023-08-22
Study Status v12
Primary completion date2024-11→2026-11
Completion date2024-11→2026-11
Show 11 earlier versions
2023-03-01
Study Status, Eligibility, Contacts/Locations v11
Study sites8→7
Eligibility criteria+159 characters
[...] 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 [...] of bupivacaine 0.5% is greater than the maximum allowed dose Patients within 6 months of previous enrollment for surgery for contralateral mastectomy
2022-03-02
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v10
Primary completion date2023-11→2024-11
Completion date2023-11→2024-11
Eligibility criteria+16 characters
[...] illary dissection Patients scheduled for surgery at the JRSC or MSK Monmouth Exclusion Criteria: Male breast cancer patients Patients wh [...]
Study sites8 entries, revised
Memorial Sloan Kettering Monmouth (ConsentAll andProtocol follow-up onlyActivities)
2021-10-18
Study Status v9
Re-verified, no change to tracked fields
2021-07-12
Study Status, Study Description, Eligibility, Contacts/Locations v8
Primary completion date2022-11→2023-11
Completion date2022-11→2023-11
Study sites7→8
Eligibility criteria+7 characters
[...] who are non-English speaking Patients having any immediate breast reconstructive procedure Patients are having bilateral maste [...]
2020-11-19
Study Status v7
Primary completion date2021-11→2022-11
Completion date2021-11→2022-11
2019-11-18
Study Status, Contacts/Locations v6
Primary completion date2020-11→2021-11
Completion date2020-11→2021-11
Study sites7 entries, revised
Memorial Sloan Kettering Rockville Centre (Consent and follow-up only)Bergen
2019-05-02
Study Status, Contacts/Locations v5
Study sites6→7
2018-11-21
Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility v4
Enrollment target140→144
Eligibility criteria-38 characters
Inclusion Criteria: Eligible patients will be femalesFemales ≥ 18 years of age Patients undergoing unilateral mastectomy with or without sentinel node biopsySLNB or axillary dissection Patients scheduled for surgery at the JRSC Exclusion Criteria: Male breast cancer patients Patient [...]
2018-05-02
3 amendments v1-v3
3 re-verifications since 2017-11-22, no change to tracked fields
2017-11-20
Original filing
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.
Trial Details
NCT Number NCT03351348
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Breast Cancer
Enrollment 165 participants
Start Date 2017-11-16
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-08-04