Effect of Opioids in Neuropathic Pain in Postherpetic Patients (VHPRG-HDRPH)

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.

Study Overview

• Status: Unknown
• Conditions: Neuralgia, Postherpetic
• Intervention / Treatment: Drug: Remifentanil

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Wilhelminenspital der Stadt Wien
    • Contact: Burkhard Gustroff, Prof., Dr.; Phone Number: 00431491504001; Email: burkhard.gustroff@meduniwien.ac.at
    • Principal Investigator: Burkhard Gustroff, Prof., Dr.
  • Vienna, Austria, 1090
    • General Hospital Vienna, Medical University of Vienna
    • Contact: Bernhard Roessler, Dr; Phone Number: 00431404006428; Email: bernhard.roessler@meduniwien.ac.at
    • Contact: Burkhard Gustorff, Prof., Dr.; Phone Number: 00431491504001; Email: burkhard.gustorff@meduniwien.ac.at
    • Sub-Investigator: Bernhard Roessler, Dr
    • Principal Investigator: Astrid Chiari, Prof., Dr.
    • Sub-Investigator: Burkhard Gustroff, Prof., Dr.
    • Sub-Investigator: Juergen Sandkuehler, Prof., Dr. PHD
    • Sub-Investigator: Ruth Drdla, Dr. PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Stimulus-response (SR)-function	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pinprick	Area of secondary hyperalgesia assessed by pinprick	7 days
Area of dynamic allodynia	Brush, Q Tip, Cotton Wool	7 days
NRS	Pain according to numeric rating scale (NRS)	7 days
Mechanical pain threshold	Mechanical pain threshold measured with v. Frey Filaments	7 days
HPPT	Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)	7 days
HPTT	Heat pain tolerance threshold (HPTT) measured with TSA	7 days
Coolness	Coolness perception threshold measured with TSA	7 days
Warmth	Warmth perception threshold measured with TSA	7 days
LDPI	Laser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome	7 days

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Vienna General Hospital; WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): March 1, 2011
• Study Completion (Anticipated): March 1, 2011

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 9, 2010
• First Posted (Estimate): April 12, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2010
• Last Update Submitted That Met QC Criteria: April 9, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Remifentanil; Zoster; Hyperalgesia; Postherpetic neuralgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: VHPRG-HighDoseRemiPostHerpetic