Effect of Opioids in Neuropathic Pain in Postherpetic Patients

NCT01102101 | Unknown Phase 3

• 1 other identifier: VHPRG-HighDoseRemiPostHerpetic
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuralgia, Postherpetic

Keywords

Remifentanil; Hyperalgesia; Zoster; Postherpetic neuralgia

Outcome Measures

Primary Outcomes (1)

• Stimulus-response (SR)-function

  7 days

Secondary Outcomes (9)

• Pinprick

  7 days

• Area of dynamic allodynia

  7 days

• NRS

  7 days

• Mechanical pain threshold

  7 days

• HPPT

  7 days

Interventions

Remifentanil DRUG

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.

Also known as: Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds: collaborator
• Vienna General Hospital: collaborator

Study Sites (2)

General Hospital Vienna, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Wilhelminenspital der Stadt WIen

Vienna, Vienna, 1160, Austria

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic; Hyperalgesia; Herpes Zoster

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatosensory Disorders; Sensation Disorders; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 12, 2010
• Study Start: August 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 12, 2010

Record last verified: 2010-04

Locations

AU (2)