CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Lidocaine +1 moredrug
Likely dose
Lidocaine 7mg/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/NCT02229578
NCT02229578Phase 4Completed

Lidocaine In The Treatment of Post-operative Pain Management From a Donor Site After Split Thickness Skin Graft Harvesting Following Thermal Injury

University of Florida·interventional·Posted Sep 1, 2014·Updated Jul 1, 2024

In Brief

A Phase 4 clinical trial evaluating Lidocaine and Placebo for Pain. Completed, enrolled 34 participants across 2 sites.

Detailed Summary

Burn pain is known to be one the most severe forms of acute pain often requiring large amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for controlling pain in various settings including dressing changes of burns. The aim of this study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and narcotic requirements when applied to donor graft sites while at the same time not interfering with the standard of care TheraBond dressing. During this study the investiagtors will be monitoring for evidence of delayed wound healing, and surgical site infection.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 1, 2014
Enrollment StartSep 1, 2014
Primary CompletionNov 14, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 11.8 years ago

Interventions

Lidocainedrug

Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.

Placebodrug

Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.