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Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

Primary Purpose

Pain, Hyperalgesia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lidoderm Patch
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Hyperalgesia, capsaicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UCSD Center for Pain and Palliative Care

Outcomes

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.

Full Information

First Posted
September 7, 2006
Last Updated
September 7, 2006
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00373893
Brief Title
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Official Title
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of California, San Diego

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hyperalgesia
Keywords
Pain, Hyperalgesia, capsaicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lidoderm Patch
Primary Outcome Measure Information:
Title
Neurosensory testing
Title
Four neurosensory tests: warm and cold sensation,warm/cold pain/touch/mechanical pain.
Title
Warm and cold sensation measured w/a Thermal Sensory
Title
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
Title
Mechanical pain will be measured using von Frey hairs. Endpoint will be pain.
Secondary Outcome Measure Information:
Title
Allodynia and Hyperalgesia
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S. Wallace, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Center for Pain and Palliative Care
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9197294
Citation
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.
Results Reference
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PubMed Identifier
11808827
Citation
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.
Results Reference
background
PubMed Identifier
11009231
Citation
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.
Results Reference
background
PubMed Identifier
9197296
Citation
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.
Results Reference
background
PubMed Identifier
9728835
Citation
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.
Results Reference
background
PubMed Identifier
8233532
Citation
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.
Results Reference
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Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

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