A Study Assessing Bupivacaine for Pain Control After Mastectomy

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Full Title

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

Purpose

The standard approach to controlling pain after mastectomy includes intravenous and oral pain-relieving medications. In this study, researchers are determining if adding a long-acting local anesthetic, bupivacaine, into the wound at the end of the operation is more effective at reducing pain than the standard medications alone for women having a mastectomy on one side with no immediate reconstruction afterward.

Patients will be randomly assigned to receive the bupivacaine or a placebo (inactive drug) at the end of surgery, in addition to receiving their usual pain medications.

Who Can Join

This study is open to women age 18 and older who are having mastectomy on one side of the body without immediate reconstruction. They must be able to speak English so they can answer study questions about their pain.

For more information about this study and to inquire about eligibility, please contact Dr. Laurie Kirstein at 848-225-6121.

Protocol

17-576

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT03351348