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Ropivacaine Hydrochloride via Paravertebral Blocks before Surgery in Decreasing Pain in Patients with Breast Cancer

Trial Status: Active

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.

Inclusion Criteria

  • Choose bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction
  • Have no inflammatory breast cancers
  • Be aware of the nature of her malignancy
  • Understand the study purpose, requirements, and risks
  • Be able and willing to give informed consent

Exclusion Criteria

  • Any concurrent opioid analgesic use (baseline opioid use must be 0 to be eligible)
  • Liver dysfunction and/ or cirrhosis
  • Renal insufficiency, with creatinine greater than 1.5 mg/mL
  • Patients weighing less than 50 Kg
  • Concurrent use of the selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine (Luvox)
  • Having a tattoo on the back that is too large to permit PVB injections (as determined by the provider performing the procedure)

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Gedge Rosson
Phone: 410-955-9477

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Johns Hopkins University / Sidney Kimmel Cancer Center

Principal Investigator
Gedge Rosson

  • Primary ID J1284
  • Secondary IDs NCI-2014-01365, 311945, NA_00075957
  • Clinicaltrials.gov ID NCT02161705