CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Not stated in 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/NCT01126359
NCT01126359N/ACompleted

Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial

University of Utah·interventional·Posted May 19, 2010·Updated May 29, 2014

In Brief

A clinical study evaluating Lidocaine and Placebo-Saline for Pain. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2010
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.1 years ago

Interventions

Lidocainedrug

Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.

Placebo-Salinedrug

Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.