The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

Early Phase 1

Completed

• Conditions: Pain; Impairment, Light Touch Sensation
• Interventions: Device: pulsed ultrasound device with lidocaine; Other: off device; Device: continuous ultrasound device with lidocaine

• Registration Number: NCT01404468
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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.

Detailed Description

Lidocaine is a common local anaesthetic drug that is used topically to relieve pain,itching and burning, and also for minor surgery.However,its application via this conductive method,has been confined to surface anaesthesia because it seems that it is not possible to have a deep transmission with local drug massage, without injection or systematic administration.On the other hand,the injection of lidocaine can lead to tissue injury and pain,and its use is not advised in children. Phonophoresis is one of the common procedures for reducing these problems. Therefore, the main aim of this study was to compare the two modes of therapeutic ultrasound by assessing the effect of lidocaine gel phonophoresis on percutaneous absorption and sensory blockade.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-09
• Study Completion: 2010-10
• Status Verified: 2011-03
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-27
• Last Update Submitted: 2011-07-27
• Study First Posted: 2011-07-28
• Last Update Posted: 2011-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Men and women aged 18 to 25 years

Exclusion Criteria

• individuals who had a disease that could affect the experiment, such as systemic disease,impairment of the sensory system(e.g.neuropathy,diabetes),cardiovascular disorders(e.g. increased blood pressure),pain due to an injury to the upper extremity,tumours,malignant and precancerous tissue,acute infection and broken skin in the area; and individuals taking medication to relieve disease symptoms were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pulsed	pulsed ultrasound device with lidocaine	-
control	off device	-
continuous	continuous ultrasound device with lidocaine	-

Primary Outcome Measures

Name	Time	Method
Two-point discrimination,touch and maximum pain thresholds	imediately after finishing the application of ultrasound (5 minutes after intervention)

Trial Locations

Locations (1)

Samaneh Ebrahimi; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of