- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00373893
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
September 7, 2006 updated by: University of California, San Diego
To determine the effects of Lidocaine patch on the pain and hyperalgesia induced by intradermal capsaicin
Study Overview
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.
Study Type
Interventional
Enrollment
12
Phase
- 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
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California
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La Jolla, California, United States, 92037
- UCSD Center for Pain and Palliative Care
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Neurosensory testing
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Four neurosensory tests: warm and cold sensation,warm/cold pain/touch/mechanical pain.
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Warm and cold sensation measured w/a Thermal Sensory
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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
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Mechanical pain will be measured using von Frey hairs. Endpoint will be pain.
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Secondary Outcome Measures
Outcome Measure |
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Allodynia and Hyperalgesia
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark S. Wallace, MD, University of California, San Diego
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
- Wallace MS, Laitin S, Licht D, Yaksh TL. Concentration-effect relations for intravenous lidocaine infusions in human volunteers: effects on acute sensory thresholds and capsaicin-evoked hyperpathia. Anesthesiology. 1997 Jun;86(6):1262-72. doi: 10.1097/00000542-199706000-00006.
- Wallace MS, Ridgeway B 3rd, Leung A, Schulteis G, Yaksh TL. Concentration-effect relationships for intravenous alfentanil and ketamine infusions in human volunteers: effects on acute thresholds and capsaicin-evoked hyperpathia. J Clin Pharmacol. 2002 Jan;42(1):70-80. doi: 10.1177/0091270002042001008. Erratum In: J Clin Pharmacol. 2007 Aug;47(8):1061.
- Ando K, Wallace MS, Braun J, Schulteis G. Effect of oral mexiletine on capsaicin-induced allodynia and hyperalgesia: a double-blind, placebo-controlled, crossover study. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):468-74. doi: 10.1053/rapm.2000.8584.
- Eisenach JC, Hood DD, Curry R, Tong C. Alfentanil, but not amitriptyline, reduces pain, hyperalgesia, and allodynia from intradermal injection of capsaicin in humans. Anesthesiology. 1997 Jun;86(6):1279-87. doi: 10.1097/00000542-199706000-00008.
- Eisenach JC, Hood DD, Curry R. Intrathecal, but not intravenous, clonidine reduces experimental thermal or capsaicin-induced pain and hyperalgesia in normal volunteers. Anesth Analg. 1998 Sep;87(3):591-6. doi: 10.1097/00000539-199809000-00018.
- Cervero F, Gilbert R, Hammond RGE, Tanner J. Development of secondary hyperalgesia following non-painful thermal stimulation of the skin: a psychophysical study in man. Pain. 1993 Aug;54(2):181-189. doi: 10.1016/0304-3959(93)90207-6.
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
December 1, 2005
Study Completion
February 1, 2006
Study Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 8, 2006
Study Record Updates
Last Update Posted (Estimate)
September 8, 2006
Last Update Submitted That Met QC Criteria
September 7, 2006
Last Verified
October 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Sensation Disorders
- Somatosensory Disorders
- Hyperalgesia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 051252
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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