Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Neuralgia, Postherpetic Clinical Trial

— VHPRG-HDRPH  

Official title:

Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01102101
• Other study ID #: VHPRG-HighDoseRemiPostHerpetic
• Status: Not yet recruiting
• Phase: Phase 3
• First received: April 6, 2010
• Last updated: April 9, 2010
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2010
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

Postherpetic neuralgia (PHN) is often associated with pain and sensory changes and is the leading type of neuropathic pain in modern clinical pain research. It is characterized by a variety of sensory patterns, which may be categorized into "irritable nociceptor" and "impairment of nociceptor". At date, several lines of evidence lead to the assumption, that mechanical hyperalgesia in PHN is based - at least in part - on central nervous processes of sensitization.

In animal studies the investigators have discovered a previously unrecognized effect of opioids, the reversal of long-term potentiation (LTP) at C-fibre synapses, i.e. an opioid-induced depotentiation. In principle, synaptic depotentiation may be permanent or transient. In our study the clinically used ultra-short acting MOR agonist remifentanil normalized synaptic strength after wash-out of the drug. At present it is not known whether opioid-induced depotentiation can be used to the benefit of pain patients.

The aim is to study the hypothesis, that pain in a group of PHN patients with predominant mechanical hyperalgesia is reversed by intravenous remifentanil at a plasma target concentration of 18ng/ml (corresponding to about 0.75 µg/kg/min) for 60 minutes compared with PHN patients of other sensory types.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suffering from PHN.

• Pain = 4 out of 10 in numeric rating scale (NRS)

• Female and male patients above the age of 18

• Ability to understand/write/read german

Exclusion Criteria:

• Zoster affecting trigeminal-, opticus region

• Any somatic pain which is stronger than the neuropathic pain

• Severe progressive disease

• Acute cardiac decompensation

• Known cardiac valve dysfunction

• Known pulmonary hypertension

• Cardiac conduction disturbance

• Active herpetic lesion

• Opioid therapy

• Asthma bronchial

• Chronic obstructive pulmonary disease >GOLD II

• Severe psychiatric condition

• Abuse of alcoholic beverages, drug abuse

• Negative neuropathic symptoms

• Pregnancy or breast feeding

• Participation in a clinical trial in the 2 weeks preceding the study

• Allergy against any medication used in the study protocol

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

Drug:
• Remifentanil
Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to approx. 0.7 µg kg-1 min-1.

Locations

Country	Name	City	State
Austria	General Hospital Vienna, Medical University of Vienna	Vienna
Austria	Wilhelminenspital der Stadt WIen	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Vienna	Vienna General Hospital, WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stimulus-response (SR)-function		7 days	No
Secondary	Pinprick	Area of secondary hyperalgesia assessed by pinprick	7 days	No
Secondary	Area of dynamic allodynia	Brush, Q Tip, Cotton Wool	7 days	No
Secondary	NRS	Pain according to numeric rating scale (NRS)	7 days	No
Secondary	Mechanical pain threshold	Mechanical pain threshold measured with v. Frey Filaments	7 days	No
Secondary	HPPT	Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)	7 days	No
Secondary	HPTT	Heat pain tolerance threshold (HPTT) measured with TSA	7 days	No
Secondary	Coolness	Coolness perception threshold measured with TSA	7 days	No
Secondary	Warmth	Warmth perception threshold measured with TSA	7 days	No
Secondary	LDPI	Laser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome	7 days	No

External Links

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