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Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

This study has been completed.
Sponsor:
Information provided by:
University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00373893
First received: September 7, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by intradermal capsaicin


Condition Intervention Phase
Pain
Hyperalgesia
Drug: Lidoderm Patch
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Neurosensory testing
  • Four neurosensory tests: warm and cold sensation,warm/cold pain/touch/mechanical pain.
  • Warm and cold sensation measured w/a Thermal Sensory
  • Touch will be measured using von Frey hairs. Calibrated von Frey hairs are filaments of varying size. The filament are selected at random and 3 successive stimuli are applied for 1.5 second at 5 second intervals per filament
  • Mechanical pain will be measured using von Frey hairs. Endpoint will be pain.

Secondary Outcome Measures:
  • Allodynia and Hyperalgesia
  • At the completion of the stimulation, areas of cutaneous allodynia and hyperalgesia will be mapped. The region of hyperalgesia will be established with a 5.18 von Frey hair, and the area of allodynia with a foam brush gently stroked on the skin.

Estimated Enrollment: 12
Study Start Date: December 2005
Estimated Study Completion Date: February 2006
Detailed Description:

A randomized, double-blinded, placebo controlled methodology will be conducted. At the session subjects will be exposed to placebo patch and lidocaine patch. Prior to study drug administration, a baseline neurosensory test on the volar aspect of both forearms will be performed and baseline vital signs will be measured. A placebo patch and a lidocaine patch will then be applied to the volar aspect of each forearm. The arms will be randomized to which arm receives placebo and which one receives the lidocaine patch. After four hours of application the right forearm patch will be removed the neurosensory testing will be repeated on the right forearm. After completing the testing, capsaicin (10µl, 10 mg/ml) will be injected intradermally on the volar aspect of the right forearm. Elicited and spontaneous pain scores, blood pressure, heart rate, and respiratory rate will be measured at the time of injection and every 2.5 minutes for 10 minutes. A McGill Pain Questionnaire will be administered at the time of capsaicin injection only. Ten minutes after the capsaicin injection, the hyperalgesic area will be established to von Frey hair, stroking, and heat; the flare response will be outlined; and neurosensory testing will performed halfway between the edge of this defined area and the capsaicin injection site. At the completion of the testing on the right forearm, the left forearm patch will be removed and the procedures described for the right forearm will be repeated for the left forearm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 and above

Exclusion Criteria:

  • Pregnancy.
  • Allergy to lidocaine
  • Current painful condition
  • Current use of analgesics for the treatment of pain
  • Lack of ability to understand the experimental protocol and to adequately communicate in English. The neurosensory testing we plan to perform requires the complete cooperation and understanding of the subject. It would be impossible to perform these studies on patients who do not adequately communicate in English.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373893

Locations
United States, California
UCSD Center for Pain and Palliative Care
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Investigators
Principal Investigator: Mark S. Wallace, MD University of California, San Diego
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00373893     History of Changes
Other Study ID Numbers: 051252
Study First Received: September 7, 2006
Last Updated: September 7, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
Pain
Hyperalgesia
capsaicin

Additional relevant MeSH terms:
Hyperalgesia
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Somatosensory Disorders
Capsaicin
Antipruritics
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014