Local Anaesthetic Effects of Transcutaneous Amitriptyline

NCT ID: NCT00355277

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-12-31

Brief Summary

The aim of this study is to assess the local anaesthetic effects of amitriptyline applied on the skin of human volunteers, considering the differential effects on mechanic and thermic sensitivity, the local and general tolerance, and the systemic absorption of the drug. The solution used for dilution of amitriptyline is the only one known to allow transcutaneous absorption of the drug [1]. Considering that the peripheral sensitive fibre is a possible site of action of tricyclic antidepressants for relieving neuropathic pain [2,3], this is a first step study before further assessment of the therapeutic effects of transcutaneous amitriptyline.

Detailed Description

Sixteen male healthy volunteers are enrolled for this study. They receive in a randomised order on six regions of dorsal skin (after previous targetting by ink marks) the six following treatments : lidocaïne-prilocaïne anaesthetic cream (EMLA (R)), normal saline, amityptiline hydrochloride diluted in solution of water (%), isopropanol (%) , glycerol (%), titrated with sodium hydroxide for pH=8.5, at four different concentrations (0,25, 50 and 100 mM). The person in charge of local application does not participate to further examination. Immediately after one hour of application, the volunteer is examined, and then every 2 hours during 8 hours, and 24 hours after the end if application. Every trial includes, for every treated area, (a) measurement of sensitive and nociceptive threshold to Von Frey hair application, (b) assessment of sensation induced by cold and heat after Rolltemp TM application, (c) measurement of sensitive threshold to cold, then sensitive and nociceptive thresholds to heat with Thermotest TM, (d) clinical evaluation of tolerance to the treatment, (e) blood sampling for measuring amitriptylinemia (HPLC). The possible residual anaesthetic effects of the treatment are assessed one and three weeks after the application, by measurement of sensitive and nociceptive threshold to Von Frey hair application. The statistical analysis will use two-way ANOVA, considering the following factors : treatment, time, order, subject, subject/order.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Amitriptyline

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• history of intolerance to amitriptyline, lidocaine or prilocaine
• cardiac predisposition to intolerance to tricyclic antidepressants

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Principal Investigators

Claude DUBRAY, Pr

Role: PRINCIPAL_INVESTIGATOR

CENTRE DE PHARMACOLOGIE CLINIQUE

Christian DUALE, Dr

Role: STUDY_DIRECTOR

CENTRE DE PHARMACOLOGIE CLINIQUE

PICKERING gisele, Dr

Role: STUDY_DIRECTOR

CENTRE DE PHARMACOLOGIE CLINIQUE

Locations

Centre de Pharmacologie Clinique /Cic

Clermont-Ferrand, Auvergne, France

Countries

France

References

Kissin I, McDanal J, Xavier AV. Topical lidocaine for relief of superficial pain in postherpetic neuralgia. Neurology. 1989 Aug;39(8):1132-3. doi: 10.1212/wnl.39.8.1132-a. No abstract available.

Reference Type: BACKGROUND

PMID: 2761713 (View on PubMed)

Sawynok J, Esser MJ, Reid AR. Antidepressants as analgesics: an overview of central and peripheral mechanisms of action. J Psychiatry Neurosci. 2001 Jan;26(1):21-9.

Reference Type: BACKGROUND

PMID: 11212590 (View on PubMed)

McQuay HJ, Tramer M, Nye BA, Carroll D, Wiffen PJ, Moore RA. A systematic review of antidepressants in neuropathic pain. Pain. 1996 Dec;68(2-3):217-27. doi: 10.1016/s0304-3959(96)03140-5.

Reference Type: BACKGROUND

PMID: 9121808 (View on PubMed)

Duale C, Daveau J, Cardot JM, Boyer-Grand A, Schoeffler P, Dubray C. Cutaneous amitriptyline in human volunteers: differential effects on the components of sensory information. Anesthesiology. 2008 Apr;108(4):714-21. doi: 10.1097/ALN.0b013e3181672632.

Reference Type: RESULT

PMID: 18362604 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/18362604

Related Info

Other Identifiers

CHU63-0014

Identifier Type: -

Identifier Source: org_study_id