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Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Effect of Opioids in Neuropathic Pain in Postherpetic Patients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01102101
Acronym
VHPRG-HDRPH
Enrollment
30
Registered
2010-04-12
Start date
2010-08-31
Completion date
2011-03-31
Last updated
2010-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuralgia, Postherpetic

Keywords

Remifentanil, Hyperalgesia, Zoster, Postherpetic neuralgia

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.

Interventions

DRUGRemifentanil

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.

Sponsors

WWTF, Wiener Wissenschafts-, Forschungs- und Technologiefonds
CollaboratorUNKNOWN
Vienna General Hospital
CollaboratorOTHER
Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Stimulus-response (SR)-function7 days

Secondary

MeasureTime frameDescription
Area of dynamic allodynia7 daysBrush, Q Tip, Cotton Wool
NRS7 daysPain according to numeric rating scale (NRS)
Mechanical pain threshold7 daysMechanical pain threshold measured with v. Frey Filaments
HPPT7 daysHeat pain perception threshold (HPPT) with thermal sensory analyzer (TSA)
Pinprick7 daysArea of secondary hyperalgesia assessed by pinprick
Coolness7 daysCoolness perception threshold measured with TSA
Warmth7 daysWarmth perception threshold measured with TSA
LDPI7 daysLaser Doppler Perfusion Imager (LDPI) measuring superficial perfusion of the dermatome
HPTT7 daysHeat pain tolerance threshold (HPTT) measured with TSA

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026