IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery:
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a local anesthetic drug (lidocaine) given
      during anesthesia intravenously (IV) through a needle in your vein,), can:

        1. Help decrease pain after surgery.

        2. Have you need less pain medication.

        3. Have less side effects like nausea and vomiting following your surgery.

        4. Help to prevent chronic pain.

        5. Affect recurrence of cancer after surgery.
    

Detailed description: 
      Pain after breast surgery is usually treated with narcotics; however, these are associated
      with a high incidence of side effects such as itching, nausea and vomiting, constipation,
      urinary retention and dizziness. Another modality for pain control is regional anesthesia;
      thoracic paravertebral blocks [TPVB] using local anesthetics are particularly appealing for
      breast surgery. They provide good pain control, possibly blunting surgical stress response,
      and decrease the need for anesthetic agent. However, TPVB are not widely used, and the
      inherent risk associated with their placement, such as pneumothorax, nerve injury, bleeding
      and infection, makes them less appealing to patients. From a pain management point of view,
      paravertebral blocks may be the optimal approach for reducing pain and opiate consumption
      after breast cancer surgery. In addition, retrospective data suggest a reduction in cancer
      recurrence if this technique is used. Unfortunately, this effective technique is not widely
      performed because of the risk of pneumothorax and is only used in some centers. Our intent is
      to study an alternative approach with fewer risks.

      In this study, we will test the ability of intravenous lidocaine to provide pain relief after
      breast surgery. We base our hypothesis on a number of previous trials showing significant
      benefits of intravenous local anesthetics in the setting of abdominal surgery1-4.

      Approximately 30 to 50% of patients will develop chronic pain following mastectomy5,6. It has
      been suggested that adequately treating pain in the immediate perioperative period will
      prevent chronic pain. Specifically, application of EMLA (local anesthetic) cream
      perioperatively during breast surgery has been shown to reduce the incidence of chronic pain
      development7. Perioperative administration of intravenous lidocaine may offer similar
      benefits. Therefore, we will study the incidence of chronic pain in our population after 6
      months.

      Finally, anesthetic choice during primary surgical intervention for cancer may affect
      recurrence and metastasis. A recent retrospective study suggests a profound reduction in
      recurrence in breast cancer patients receiving regional + general anesthesia as compared with
      general alone9. Similar data have been published in abstract form regarding recurrence after
      prostate surgery10. Also, Christopherson et al studied the long-term survival of 177 patients
      after resection of colon cancer in a trial of general anesthesia with and without epidural
      anesthesia and analgesia supplementation for resection of colon cancer. Epidural
      supplementation was associated with enhanced survival among patients without metastases
      before 1.46 years8. Although the mechanisms of this beneficial effect are unclear,
      attenuation of the surgical stress response, modulation of the inflammatory system, and/or
      decreased requirement for volatile anesthetics and opiates by regional anesthesia are
      possible mechanisms11. For example, the neural inputs activated during surgical stress may
      result in activation of promalignant pathways. Morphine has been shown to promote
      angiogenesis in a model of breast cancer, a key step in tumor development12. In addition,
      opiates interfere with natural killer cell function13. It is conceivable that the beneficial
      effect on recurrence might derive from low systemic level of local anesthetics attained
      during regional anesthesia. A number of studies have demonstrated significant reduction in
      opiate requirements and a decrease in the magnitude of stress response when local anesthetics
      are used intravenously1,3,4. If so, systemic administration would be a safer and a simpler
      way to reach the same goal. We therefore will compare the effect of local anesthetics given
      intravenously as compared with placebo on cancer recurrence rate.
    

Intervention name(s): Placebo; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room.; ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room.
Other intervention name(s): xylocaine; xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Breast Cancer