Lidocaine Analgesia For Removal Of Wound Vac Dressings
The purpose of this prospective study is to compare pain levels in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed after normal saline or lidocaine is injected 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 between the groups receiving saline injection and pain medications or just pain medications, compared to those with lidocaine injection and pain medications. Our objective is to disprove this null hypothesis with statistical significance.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial|
- Visual Analog Scale Pain Score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Break-through Narcotic Requirement [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Saline||
Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
|Active Comparator: Lidocaine||
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.