Comparing bupivacaine and placebo for pain control after mastectomy
Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction
This study is testing if adding a numbing medication called bupivacaine can help people feel less pain after having a mastectomy compared to just using standard pain medications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 165 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT03351348 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of bupivacaine, a numbing medication, in managing post-operative pain for patients undergoing unilateral mastectomy. Participants will receive either bupivacaine at the surgical site along with standard pain medications or standard medications alone. The goal is to determine if the addition of bupivacaine can improve pain management and reduce reliance on opioids after surgery. The study will assess patient-reported pain scores to compare outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for unilateral mastectomy with or without sentinel lymph node biopsy.
Not a fit: Patients who are non-English speaking, undergoing bilateral mastectomy, or have certain pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better pain management and reduced opioid use for patients after mastectomy.
How similar studies have performed: Other studies have shown promising results with bupivacaine for post-operative pain control, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Consent and follow-up only) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Consent and follow-up only) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (Consent and follow-up only) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Consent and follow-up only) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Consent and follow-up only) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Laurie Kirstein, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Laurie Kirstein, MD
- Email: kirsteil@mskcc.org
- Phone: 848-225-6121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.