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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Lidocaine

Criteria

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