The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

July 27, 2011 updated by: Shiraz University of Medical Sciences

Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pulsed
Device: pulsed ultrasound device with lidocaine
Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)
Other Names:
  • lidocainegel(Akron,Inc.,Lake Forest,CA,USA)
  • ultrasound(Enraf,Sonopuls 434,Netherlands)
Sham Comparator: control
Other: off device
off device with Lidocaine (approximately 2 cc) was administered transdermally
Other Names:
  • 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 )
Other Names:
  • lidocaine gel(Akron, Inc.,Lake Forest,CA,USA)
  • ultrasound (Enraf,Sonopuls 434,Netherlands)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Two-point discrimination,touch and maximum pain thresholds
Time Frame: imediately after finishing the application of ultrasound (5 minutes after intervention)
imediately after finishing the application of ultrasound (5 minutes after intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Principal Investigator: samaneh ebrahimi, PhD student, PhD student in shiraz university of medical sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 28, 2011

Study Record Updates

Last Update Posted (Estimate)

July 28, 2011

Last Update Submitted That Met QC Criteria

July 27, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84-7.33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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