Effect of Opioids in Neuropathic Pain in Postherpetic Patients (VHPRG-HDRPH)
Primary Purpose
Neuralgia, Postherpetic
Status
Unknown status
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional basic science trial for Neuralgia, Postherpetic focused on measuring Remifentanil, Hyperalgesia, Zoster, Postherpetic neuralgia
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
Sites / Locations
- General Hospital Vienna, Medical University of Vienna
- Wilhelminenspital der Stadt WIen
Outcomes
Primary Outcome Measures
Stimulus-response (SR)-function
Secondary Outcome Measures
Pinprick
Area of secondary hyperalgesia assessed by pinprick
Area of dynamic allodynia
Brush, Q Tip, Cotton Wool
NRS
Pain according to numeric rating scale (NRS)
Mechanical pain threshold
Mechanical pain threshold measured with v. Frey Filaments
HPPT
Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)
HPTT
Heat pain tolerance threshold (HPTT) measured with TSA
Coolness
Coolness perception threshold measured with TSA
Warmth
Warmth perception threshold measured with TSA
LDPI
Laser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome
Full Information
NCT ID
NCT01102101
First Posted
April 6, 2010
Last Updated
April 9, 2010
Sponsor
Medical University of Vienna
Collaborators
WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds, Vienna General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01102101
Brief Title
Effect of Opioids in Neuropathic Pain in Postherpetic Patients
Acronym
VHPRG-HDRPH
Official Title
Effect of Opioids in Neuropathic Pain in Postherpetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
Collaborators
WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds, Vienna General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Postherpetic
Keywords
Remifentanil, Hyperalgesia, Zoster, Postherpetic neuralgia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stimulus-response (SR)-function
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Pinprick
Description
Area of secondary hyperalgesia assessed by pinprick
Time Frame
7 days
Title
Area of dynamic allodynia
Description
Brush, Q Tip, Cotton Wool
Time Frame
7 days
Title
NRS
Description
Pain according to numeric rating scale (NRS)
Time Frame
7 days
Title
Mechanical pain threshold
Description
Mechanical pain threshold measured with v. Frey Filaments
Time Frame
7 days
Title
HPPT
Description
Heat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)
Time Frame
7 days
Title
HPTT
Description
Heat pain tolerance threshold (HPTT) measured with TSA
Time Frame
7 days
Title
Coolness
Description
Coolness perception threshold measured with TSA
Time Frame
7 days
Title
Warmth
Description
Warmth perception threshold measured with TSA
Time Frame
7 days
Title
LDPI
Description
Laser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
General Hospital Vienna, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernhard Roessler, Dr
Phone
00431404006428
Email
bernhard.roessler@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Burkhard Gustorff, Prof., Dr.
Phone
00431491504001
Email
burkhard.gustorff@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Bernhard Roessler, Dr
First Name & Middle Initial & Last Name & Degree
Astrid Chiari, Prof., Dr.
First Name & Middle Initial & Last Name & Degree
Burkhard Gustroff, Prof., Dr.
First Name & Middle Initial & Last Name & Degree
Juergen Sandkuehler, Prof., Dr. PHD
First Name & Middle Initial & Last Name & Degree
Ruth Drdla, Dr. PhD
Facility Name
Wilhelminenspital der Stadt WIen
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burkhard Gustroff, Prof., Dr.
Phone
00431491504001
Email
burkhard.gustroff@meduniwien.ac.at
First Name & Middle Initial & Last Name & Degree
Burkhard Gustroff, Prof., Dr.
12. IPD Sharing Statement
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Effect of Opioids in Neuropathic Pain in Postherpetic Patients
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