CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 1.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01204242
NCT01204242Phase 2Completed
CompareCT.gov

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

University of Virginia·interventional·Posted Sep 17, 2010·Updated Mar 24, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo and Lidocaine for Breast Cancer. Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 17, 2010
Enrollment StartAug 1, 2009
Primary CompletionNov 8, 2018
TodayJul 2, 2026
Enrollment to primary: 9.3 yearsPosted 15.8 years ago

Interventions

Placebodrug

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.

Lidocainedrug

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.