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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Medical University of Vienna.
Recruitment status was:  Not yet recruiting
WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds
Vienna General Hospital
Information provided by:
Medical University of Vienna Identifier:
First received: April 6, 2010
Last updated: April 9, 2010
Last verified: April 2010

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.

Condition Intervention Phase
Neuralgia, Postherpetic Drug: Remifentanil Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Stimulus-response (SR)-function [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Pinprick [ Time Frame: 7 days ]
    Area of secondary hyperalgesia assessed by pinprick

  • Area of dynamic allodynia [ Time Frame: 7 days ]
    Brush, Q Tip, Cotton Wool

  • NRS [ Time Frame: 7 days ]
    Pain according to numeric rating scale (NRS)

  • Mechanical pain threshold [ Time Frame: 7 days ]
    Mechanical pain threshold measured with v. Frey Filaments

  • HPPT [ Time Frame: 7 days ]
    Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)

  • HPTT [ Time Frame: 7 days ]
    Heat pain tolerance threshold (HPTT) measured with TSA

  • Coolness [ Time Frame: 7 days ]
    Coolness perception threshold measured with TSA

  • Warmth [ Time Frame: 7 days ]
    Warmth perception threshold measured with TSA

  • LDPI [ Time Frame: 7 days ]
    Laser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome

Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01102101

General Hospital Vienna, Medical University of Vienna Not yet recruiting
Vienna, Austria, 1090
Contact: Bernhard Roessler, Dr    00431404006428   
Contact: Burkhard Gustorff, Prof., Dr.    00431491504001   
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         
Wilhelminenspital der Stadt WIen Not yet recruiting
Vienna, Austria, 1160
Contact: Burkhard Gustroff, Prof., Dr.    00431491504001   
Principal Investigator: Burkhard Gustroff, Prof., Dr.         
Sponsors and Collaborators
Medical University of Vienna
WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds
Vienna General Hospital
  More Information

Responsible Party: Professor Burkhard Gustorff, Vienna Human Pain Research Group, Deparmtent of Anaesthesia, Medical University of Vienna Identifier: NCT01102101     History of Changes
Other Study ID Numbers: VHPRG-HighDoseRemiPostHerpetic
Study First Received: April 6, 2010
Last Updated: April 9, 2010

Keywords provided by Medical University of Vienna:
Postherpetic neuralgia

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics processed this record on September 20, 2017