Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
Condition: Postoperative Pain; Postoperative Nausea and Vomiting; Quality of Life
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: Ropivacaine; Saline
Intervention description: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block; Up to 0.8 mL/kg of normal saline administered
Intervention MeSH terms: Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immediate breast reconstruction; pain control; post mastectomy pain control

Summary:

      Primary Objective To determine if post-operative static pain scores differ between women
      undergoing bilateral mastectomy followed by bilateral immediate tissue expander
      reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo)
      pre-operatively placed paravertebral blocks.

      Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of
      surgery while the patient is still hospitalized (post-operative day 0). This will be
      patient-provided data. Unblinded data analysis will compare scores between treatment and
      control groups.

      Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea,
      and sleep interference differ between women undergoing bilateral mastectomy followed by
      bilateral immediate tissue expander reconstruction randomized either to ropivacaine-
      (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks.

      Pain score, opioids use, nausea, and sleep interference data will be collected via patient
      self-report. When possible (i.e., while hospitalized) objective data on opioids and other
      pain medication administered to the patient will be used.

      Tertiary Objectives To determine if long-term changes in Quality of Life scores [the 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 reconstruction randomized either to ropivacaine- (treatment) or
      saline- (placebo) pre-operatively placed paravertebral blocks.

      This data will be collected via validated questionnaires through patient interviews at
      3-months, 2-years, and 4-years (±14 days) after surgery.

      Once enrolled in the study, participants will be encouraged to remain in the study for the 4
      years following surgery in order to get final pain scores and quality-of-life/health outcome
      survey information. Participants who cannot be contacted after several phone attempts and the
      sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year
      outcome assessments will be considered lost to follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be Female aged 18-100 years.

          -  Choose 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 SSRI antidepressant fluvoxamine (Luvox).