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Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

NCT ID: NCT00373893

Last Updated: 2006-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Hyperalgesia

Keywords

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Pain Hyperalgesia capsaicin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Lidoderm Patch

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Principal Investigators

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Mark S. Wallace, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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UCSD Center for Pain and Palliative Care

La Jolla, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9197294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11808827 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11009231 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9197296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9728835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8233532 (View on PubMed)

Other Identifiers

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051252

Identifier Type: -

Identifier Source: org_study_id