The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage
The optimisation of drug absorption through skin is of great value in modern therapy.Phonophoresis is the use of therapeutic ultrasound to increase percutaneous drug absorption. However,few studies have compared pulsed and continuous modes of therapeutic ultrasound.This study compared these two modes by investigating the effect of lidocaine phonophoresis on sensory blockade.
Ninety-three healthy volunteers, assigned at random to one of three ultrasound groups:pulsed(ultrasound+lidocaine),continuous(ultrasound+lidocaine)and control(sham ultrasound+lidocaine).
Lidocaine was administered transdermally using a transducer.Two point discrimination, touch and maximum pain thresholds were assessed before and after the intervention in each group.
Pulsed ultrasound with topical lidocaine gel induced greater anaesthetic effect compared with continuous ultrasound with topical lidocaine gel and lidocaine application alone. The mechanical properties of pulsed ultrasound appear to be responsible for greater drug penetration.
|Pain Impairment, Light Touch Sensation||Device: pulsed ultrasound device with lidocaine Other: off device Device: continuous ultrasound device with lidocaine||Early Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?|
- Two-point discrimination,touch and maximum pain thresholds [ Time Frame: imediately after finishing the application of ultrasound (5 minutes after intervention) ]
|Study Start Date:||March 2006|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
|Active Comparator: pulsed||
Device: pulsed ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)
|Sham Comparator: control||
Other: off device
off device with Lidocaine (approximately 2 cc) was administered transdermally
Other Name: ultrasound(Enraf,Sonopuls 434,Netherlands)
|Active Comparator: continuous||
Device: continuous ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404468
|Iran, Islamic Republic of|
|Shiraz, Fars, Iran, Islamic Republic of, 0098|
|Principal Investigator:||samaneh ebrahimi, PhD student||PhD student in shiraz university of medical sciences|