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IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT01204242
First received: September 15, 2010
Last updated: August 9, 2011
Last verified: August 2011

September 15, 2010
August 9, 2011
August 2009
Not Provided
opiate consumption [ Time Frame: hospital discharge/ days 0-7 ] [ Designated as safety issue: No ]
We hypothesize that intraoperative use of intravenous lidocaine (as compared with placebo) will result in: decreased opiate consumption (primary endpoint), less pain, less fatigue and earlier postoperative discharge.
opiate consumption [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
We hypothesize that intraoperative use of intravenous lidocaine (as compared with placebo) will result in: decreased opiate consumption (primary endpoint), less pain, less fatigue and earlier postoperative discharge.
Complete list of historical versions of study NCT01204242 on ClinicalTrials.gov Archive Site
  • chronic pain [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    We hypothesize that patients receiving IV lidocaine will report less pain than those in the placebo group at 6 months following surgery.
  • cancer recurrence [ Time Frame: yearly for 5 years after surgery ] [ Designated as safety issue: No ]
    We hypothesize that patients in the IV lidocaine group will have a lower rate of cancer recurrence than those in the placebo group at 5 years following surgery.
Same as current
Not Provided
Not Provided
 
IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence
IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery: Effects on Postoperative Recovery and Cancer Recurrence

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Breast Cancer
  • Drug: Placebo

    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.

  • Drug: Lidocaine

    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.

  • Placebo Comparator: Placebo

    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.

    Intervention: Drug: Placebo
  • Experimental: Lidocaine

    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.

    Intervention: Drug: Lidocaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
80
Not Provided
Not Provided

Inclusion Criteria:

  1. informed consent
  2. age older than 18 to 80 years (inclusive)
  3. scheduled for mastectomy because of breast cancer
  4. American Society of Anesthesiologists (ASA) physical classification classes I - III

Exclusion Criteria:

  1. Allergy to local anesthetics, fentanyl or morphine
  2. severe cardiovascular disease (myocardial infarction within 6 months), profoundly decreased left ventricular function (ejection fraction <40%) or high-grade arrhythmias
  3. severe liver disease (known AST or ALT or billirubin >2.5 times the upper limit of normal)
  4. renal impairment (creatinine clearance less than 60)
  5. pregnant or breast feeding
  6. patient is enrolled in another study or have been in one in the last 30 days
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01204242
13957
Yes
Mohamed Tiouririne , MD, University of Virginia Department of Anesthesiology
University of Virginia
Not Provided
Principal Investigator: Mohammed Tiouririne, MD UVA Dept of Anesthesiology
University of Virginia
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP