Status:
RECRUITING
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 postope...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT03351348
Start Date
November 16 2017
End Date
November 1 2026
Last Update
August 26 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent and follow-up only)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack, New York, United States, 11725