Effect of Opioids in Neuropathic Pain in Postherpetic Patients

NCT ID: NCT01102101

Last Updated: 2010-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds

UNKNOWN

Sponsor Role: collaborator

Vienna General Hospital

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Vienna Human Pain Research Group, Deparmtent of Anaesthesia, Medical University of Vienna

Locations

General Hospital Vienna, Medical University of Vienna

Vienna, Vienna, Austria

Wilhelminenspital der Stadt WIen

Vienna, Vienna, Austria

Countries

Austria

Facility Contacts

Bernhard Roessler, Dr

Role: primary

bernhard.roessler@meduniwien.ac.at

00431404006428

Burkhard Gustorff, Prof., Dr.

Role: backup

burkhard.gustorff@meduniwien.ac.at

00431491504001

Burkhard Gustroff, Prof., Dr.

Role: primary

burkhard.gustroff@meduniwien.ac.at

00431491504001

Other Identifiers

VHPRG-HighDoseRemiPostHerpetic

Identifier Type: -

Identifier Source: org_study_id