Status:
COMPLETED
IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery:
Lead Sponsor:
University of Virginia
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
Brief 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 surg...
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 a...
Eligibility Criteria
Inclusion
- informed consent
- age older than 18 to 80 years (inclusive)
- scheduled for mastectomy because of breast cancer
- American Society of Anesthesiologists (ASA) physical classification classes I - III
Exclusion
- Allergy to local anesthetics, fentanyl or morphine
- severe cardiovascular disease (myocardial infarction within 6 months), profoundly decreased left ventricular function (ejection fraction \<40%) or high-grade arrhythmias
- severe liver disease (known AST or ALT or billirubin \>2.5 times the upper limit of normal)
- renal impairment (creatinine clearance less than 60)
- pregnant or breast feeding
- patient is enrolled in another study or have been in one in the last 30 days
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2018
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01204242
Start Date
August 1 2009
End Date
November 8 2018
Last Update
March 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908