Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

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

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

144

Study ID:

NCT03351348

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 8 Locations for this study

See Locations Near You

Hartford Healthcare Cancer Alliance (Data collection only)
Hartford Connecticut, 06102, United States More Info
Niamey Wilson, MD
Contact
203-694-5200
Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)
Basking Ridge New Jersey, 07920, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown New Jersey, 07748, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121
Memorial Sloan Kettering Commack (Consent and follow-up only)
Commack New York, 11725, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121
Memorial Sloan Kettering Westchester (Consent and follow-up only)
Harrison New York, 10604, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121
Leslie Sarraf, MD
Contact
212-639-8415
Laurie Kirstein, MD
Principal Investigator
Memorial Sloan Kettering Nassau (Consent and follow-up only)
Uniondale New York, 11553, United States More Info
Laurie Kirstein, MD
Contact
848-225-6121

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

144

Study ID:

NCT03351348

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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