Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Paravertebral Block; Propofol; Fentanyl; Ropivacaine; Midazolam
Intervention description: Paravertebral block given as a bolus injection into the paravertebral space.; 2-2.5 mg/kg IV over 1-4 hours during surgery.; 50-250 mcg IV over 1-4 hours during surgery.; Ropivacaine given by injection into the paravertebral space along the spinal canal.; 0.08 mg/kg IV over 1-4 hours during the surgery.
Intervention MeSH terms: Midazolam; Fentanyl; Propofol; Ropivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Reconstructive Surgery; Paravertebral Block; Anesthesia; Propofol; Fentanyl; Ropivacaine; Midazolam

Summary:

      Primary Objective:

      To determine whether the use of a paravertebral block in patients undergoing reconstructive
      surgery for breast cancer results in decreased immediate post-operative pain compared with
      patients having only general anesthesia.

      Secondary Objectives:

        1. To determine whether the use of a paravertebral block in patients undergoing
           reconstructive surgery for breast cancer results in decreased post-operative pain in the
           first 24 hours after surgery compared with patients having only general anesthesia.

        2. To determine whether the use of a paravertebral block in patients undergoing
           reconstructive surgery for breast cancer results in decreased post-operative nausea and
           vomiting in the first 24 hours as compared with patients having only general anesthesia.

        3. To determine whether the use of a paravertebral block in patients undergoing
           reconstructive surgery for breast cancer results in a decreased length of hospital stay
           compared with patients having only general anesthesia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients that consent to participate

          2. Patients undergoing reconstructive breast surgery either in combination with oncologic
             surgery or alone

          3. Patients that are female

          4. Patients that are over the age of 18

          5. Patients on anti-coagulants or other blood thinning medications will be eligible for
             inclusion if they stop taking these medications for at least the time specified below
             prior to date of surgery: Low molecular weight heparin must stop at least 36 hours
             prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix
             and NSAIDs must stop at least 7 days prior to surgery.

        Exclusion Criteria:

          1. Patients on chronic anti-emetics (ie. chronic= more than once every two days for
             greater than 2 weeks)

          2. Patients on chronic pain medication (ie. chronic= more than once every two days for
             greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's

          3. Patients with BMI<20 or >40

          4. Patients that are pregnant

          5. Patients with chronic pain syndromes.

          6. Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be
             excluded from this trial as this would be a contraindication