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Completed

NCT Number: NCT01404468

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.

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Key information

Conditions

Pain Impairment, Light Touch Sensation Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Samaneh Ebrahimi

Shiraz, Fars, 0098, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulsed ultrasound device with lidocaine

Device

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)

off device

Other

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

Other names: ultrasound(Enraf,Sonopuls 434,Netherlands)

continuous ultrasound device with lidocaine

Device

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)

Primary outcomes

  1. Two-point discrimination,touch and maximum pain thresholds

    Time frame: imediately after finishing the application of ultrasound (5 minutes after intervention)

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Jul 28, 2011
Registry last updated
Jul 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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