The Phonophoresis of Lidocaine Gel and Its Effect on Sensory Blockage

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01404468
First received: July 21, 2011
Last updated: July 27, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Pain
Impairment, Light Touch Sensation
Device: pulsed ultrasound device with lidocaine
Other: off device
Device: continuous ultrasound device with lidocaine
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Lidocaine Phonophoresis on Sensory Blockade: Pulsed or Continuous Mode of Therapeutic Ultrasound?

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Two-point discrimination,touch and maximum pain thresholds [ Time Frame: imediately after finishing the application of ultrasound (5 minutes after intervention) ] [ Designated as safety issue: No ]

Enrollment: 93
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 )
Other Names:
  • lidocaine gel(Akron, Inc.,Lake Forest,CA,USA)
  • ultrasound (Enraf,Sonopuls 434,Netherlands)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404468

Locations
Iran, Islamic Republic of
Samaneh Ebrahimi
Shiraz, Fars, Iran, Islamic Republic of, 0098
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Principal Investigator: samaneh ebrahimi, PhD student PhD student in shiraz university of medical sciences
  More Information

No publications provided by Shiraz University of Medical Sciences

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: rehabilitation school boss, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01404468     History of Changes
Other Study ID Numbers: 84-7.33
Study First Received: July 21, 2011
Last Updated: July 27, 2011
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014