Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia

NCT00373893 | Completed Phase 1

• 1 other identifier: 051252
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Hyperalgesia

Keywords

Pain; Hyperalgesia; capsaicin

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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.

Interventions

Lidoderm Patch DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Center for Pain and Palliative Care

La Jolla, California, 92037, United States

Location

Related Publications (6)

• 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.

  PMID: 9197294 BACKGROUND

• 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.

  PMID: 11808827 BACKGROUND

• 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.

  PMID: 11009231 BACKGROUND

• 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.

  PMID: 9197296 BACKGROUND

• 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.

  PMID: 9728835 BACKGROUND

• 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.

  PMID: 8233532 BACKGROUND

MeSH Terms

Conditions

Pain; Hyperalgesia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mark S. Wallace, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: December 1, 2005
• Study Completion: February 1, 2006
• Last Updated: September 8, 2006

Record last verified: 2005-10

Locations

US (1)