RecruitingPhase 3NCT03351348

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

Double Blind, Randomized, Placebo Controlled Trial of Locally Instilled Bupivacaine in the Surgical Bed After Unilateral Mastectomy Without Reconstruction

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

165 participants

Start Date

Nov 16, 2017

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether injecting a local anesthetic (bupivacaine) into the surgical site after a single breast removal (mastectomy) can reduce pain after the operation compared to a placebo (inactive injection). **You may be eligible if...** - You are 18 years or older - You are scheduled to have a single (one-sided) mastectomy, with or without removal of lymph nodes from the armpit - Your surgery is planned at a specific participating hospital - You previously had the other breast removed more than 6 months ago **You may NOT be eligible if...** - You do not speak English - You are having immediate breast reconstruction at the same time as the mastectomy - You are having both breasts removed at the same time - You already have pain higher than a 3 out of 10 (unrelated to the cancer) before the surgery - You have an allergy to local anesthetics Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacaine

The intervention in this study is the insertion of 20cc of 0.5% bupivacaine via a drain into the mastectomy wound for 2 hours ± 30 minutes postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.

BEHAVIORALpatient-reported pain scores

Will be recorded by the nurse in the PACU as per usual practice. Patients will be given a follow-up Brief Pain Inventory (short form) 6 months and 1 year after surgery to assess their level of chronic pain. Patients may be discharged when table either on the day of surgery or post-operative day 1 (on pill diary for same-day discharge patients).

OTHERsaline

The intervention in this study is the insertion of 20cc of saline via a drain into the mastectomy wound for 2 ± 30 minutes hours postoperatively in patients undergoing unilateral mastectomy without breast reconstruction +/- SLNB, +/- axillary dissection.