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The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

NCT01404468 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2011-07-28

No results posted yet for this study

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.

Conditions

  • Pain
  • Impairment, Light Touch Sensation

Interventions

DEVICE

pulsed ultrasound device with lidocaine

Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)

OTHER

off device

off device with Lidocaine (approximately 2 cc) was administered transdermally

DEVICE

continuous ultrasound device with lidocaine

Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Principal Investigators

  • samaneh ebrahimi, PhD student · PhD student in shiraz university of medical sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-09-30
Completion
2010-10-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404468 on ClinicalTrials.gov