Clinical trial NCT01102101: Effect of Opioids in Neuropathic Pain in Postherpetic Patients
Official title: Effect of Opioids in Neuropathic Pain in Postherpetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neuralgia, Postherpetic
Keywords: Remifentanil
Hyperalgesia
Zoster
Postherpetic neuralgia
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds
name: Vienna General Hospital
First posted: 2010-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Stimulus-response (SR)-function
timeFrame: 7 days
Secondary outcomes:
measure: Pinprick
timeFrame: 7 days
measure: Area of dynamic allodynia
timeFrame: 7 days
measure: NRS
timeFrame: 7 days
measure: Mechanical pain threshold
timeFrame: 7 days
measure: HPPT
timeFrame: 7 days
measure: HPTT
timeFrame: 7 days
measure: Coolness
timeFrame: 7 days
measure: Warmth
timeFrame: 7 days
measure: LDPI
timeFrame: 7 days
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: General Hospital Vienna, Medical University of Vienna
city: Vienna
country: Austria
facility: Wilhelminenspital der Stadt WIen
Study officials:
References: