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IRB-HSR# 13957: IV Lidocaine for Patients Undergoing Primary Breast Cancer Surgery:

NCT01204242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-03-24

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Mohammed Tiouririne, MD · UVA Dept of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-01
Primary Completion
2018-11-08
Completion
2018-11-08

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01204242 on ClinicalTrials.gov