Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Phase 3

• Conditions: Neuralgia, Postherpetic

• Registration Number: NCT01102101
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-04
• Study First Submitted: 2010-04-06
• Study First Submitted QC: 2010-04-09
• Last Update Submitted: 2010-04-09
• Study First Posted: 2010-04-12
• Last Update Posted: 2010-04-12
• Study Start: 2010-08
• Primary Completion: 2011-03
• Study Completion: 2011-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Stimulus-response (SR)-function	7 days

Secondary Outcome Measures

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

Trial Locations

Locations (2)

General Hospital Vienna, Medical University of Vienna; 🇦🇹 Vienna, Austria

Wilhelminenspital der Stadt WIen; 🇦🇹 Vienna, Austria