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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Medical University of Vienna.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds
Vienna General Hospital
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01102101
First received: April 6, 2010
Last updated: April 9, 2010
Last verified: April 2010
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pinprick [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Area of secondary hyperalgesia assessed by pinprick

  • Area of dynamic allodynia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Brush, Q Tip, Cotton Wool

  • NRS [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Pain according to numeric rating scale (NRS)

  • Mechanical pain threshold [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Mechanical pain threshold measured with v. Frey Filaments

  • HPPT [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)

  • HPTT [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Heat pain tolerance threshold (HPTT) measured with TSA

  • Coolness [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Coolness perception threshold measured with TSA

  • Warmth [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Warmth perception threshold measured with TSA

  • LDPI [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102101

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

Additional Information:
No publications provided

Responsible Party: Professor Burkhard Gustorff, Vienna Human Pain Research Group, Deparmtent of Anaesthesia, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01102101     History of Changes
Other Study ID Numbers: VHPRG-HighDoseRemiPostHerpetic
Study First Received: April 6, 2010
Last Updated: April 9, 2010
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
Remifentanil
Hyperalgesia
Zoster
Postherpetic neuralgia

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 16, 2014