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NCT03351348 | RECRUITING | Breast Cancer

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

Condition or disease

Breast Cancer

Intervention/treatment

Bupivacaine

patient-reported pain scores

saline

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 144 participants
Masking : DOUBLE
Masking Description : Treatment assignments can be viewed only by the hospital pharmacists who are dispensing the study drugs.
Primary Purpose : TREATMENT
Official Title : Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction
Actual Study Start Date : 2017-11-16
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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
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
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control

Location Details

NCT03351348

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (Consent and follow-up only)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Commack (Consent and follow-up only)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (Consent and follow-up only)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (Consent and follow-up only)

Uniondale, New York, United States, 11553