This randomized clinical trial studies ropivacaine hydrochloride administered via paravertebral blocks before surgery compared to placebo in decreasing pain in patients with breast cancer. Paravertebral block is a technique use to inject local anesthetic into the spaces between the vertebrae and ropivacaine hydrochloride may reduce pain caused by surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02161705.
PRIMARY OBJECTIVES:
I. To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine (ropivacaine hydrochloride)-(treatment) pre-operatively placed paravertebral blocks or subcutaneous paravertebral saline (placebo) injections.
SECONDARY OBJECTIVES:
I. To determine if post-operative moving pain scores, opioid use, nausea, sleep interference, and length of hospital stay differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine-(treatment) pre-operatively placed paravertebral blocks or subcutaneous paravertebral saline (placebo) injections.
TERTIARY OBJECTIVES:
I. To determine if long-term changes in quality of life scores (the Research and Development [RAND]-36 Health survey, Disability of the Arm, Shoulder, and Hand [quick DASH] questionnaire, and Breast-Q scores) differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine-(treatment) pre-operatively placed paravertebral blocks or subcutaneous paravertebral saline (placebo) injections.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (ROPIVACAINE HYDROCHLORIDE): Patients receive ropivacaine hydrochloride via placed paravertebral blocks (PVB) before undergoing bilateral mastectomy and breast reconstruction surgery.
ARM II (PLACEBO): Patients receive placebo via subcutaneously (SC) paravertebral injection before undergoing bilateral mastectomy and breast reconstruction surgery.
After completion of study treatment, patients are followed up at 90 days, 2 years, and 4 years.
Lead OrganizationJohns Hopkins University/Sidney Kimmel Cancer Center
Principal InvestigatorGedge Rosson
