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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01102101
Recruitment Status : Unknown
Verified April 2010 by Medical University of Vienna.
Recruitment status was:  Not yet recruiting
First Posted : April 12, 2010
Last Update Posted : April 12, 2010
WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds
Vienna General Hospital
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Neuralgia, Postherpetic Drug: Remifentanil Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Opioids in Neuropathic Pain in Postherpetic Patients
Study Start Date : August 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

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)

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

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

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

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

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

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

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

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: April 12, 2010    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: April 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