Effect of Opioids in Neuropathic Pain in Postherpetic Patients (VHPRG-HDRPH)
Recruitment status was Not yet recruiting
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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 |
- Stimulus-response (SR)-function [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- 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) |
-
Drug: Remifentanil
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and 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. | |
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 Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Remifentanil Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 22, 2013