The PINE study: rationale and design of a randomised comparison of epidural injection of local anaesthetics and steroids versus care-as-usual to prevent postherpetic neuralgia in the elderly [ISRCTN32866390

Wim Opstelten,Gerrit A Van Essen,Theo Jm Verheij,Annette Aa Bak,Cornelis J Kalkman,Erik Buskens,Albert Jm Van Wijck,Karel Gm Moons

doi:10.1186/1471-2253-4-2

Wim Opstelten, Gerrit A Van Essen + Show 6 more

Open Access

https://doi.org/10.1186/1471-2253-4-2

Copy DOI

Journal: BMC anesthesiology	Publication Date: Jan 26, 2004
Citations: 47	License type: cc-by

Affiliation: University Medical Center Utrecht

Abstract

BackgroundPostherpetic neuralgia (PHN) is by far the most common complication of herpes zoster (HZ) and one of the most intractable pain disorders. Since PHN is seen most often in the elderly, the number of patients with this disorder is expected to increase in our ageing society. PHN may last for months to years and has a high impact on the quality of life. The results of PHN treatment are rather disappointing. Epidural injection of local anaesthetics and steroids in the acute phase of HZ is a promising therapy for the prevention of PHN. Since randomised trials on the effectiveness of this intervention are lacking, the PINE (Prevention by epidural Injection of postherpetic Neuralgia in the Elderly) study was set up. The PINE study compares the effectiveness and cost-effectiveness of a single epidural injection of local anaesthetics and steroids during the acute phase of HZ with that of care-as-usual (i.e. antivirals and analgesics) in preventing PHN in elderly patients.Methods / designThe PINE study is an open, multicenter clinical trial in which 550 elderly (age ≥ 50 yr.) patients who consult their general practitioner in the acute phase of HZ (rash < 7 days) are randomised to one of the treatment groups. The primary clinical endpoint is the presence of HZ-related pain one month after the onset of the rash. Secondary endpoints include duration and severity of pain, re-interventions aiming to treat the existing pain, side effects, quality of life, and cost-effectiveness.ConclusionThe PINE study is aimed to quantify the (cost-) effectiveness of a single epidural injection during the acute phase of HZ on the prevention of PHN.

Highlights

Postherpetic neuralgia (PHN) is by far the most common complication of herpes zoster (HZ) and one of the most intractable pain disorders
The most frequent complication of HZ is persistent pain that may last for several months or years, called postherpetic neuralgia (PHN)
PHN is commonly defined as the presence of HZrelated pain one month or more after the onset of the rash [5,6,7], whereas some use the threshold of three months [8,9]

Summary

Introduction

Postherpetic neuralgia (PHN) is by far the most common complication of herpes zoster (HZ) and one of the most intractable pain disorders. The PINE study compares the effectiveness and cost-effectiveness of a single epidural injection of local anaesthetics and steroids during the acute phase of HZ with that of care-as-usual (i.e. antivirals and analgesics) in preventing PHN in elderly patients. PHN is commonly defined as the presence of HZrelated pain one month or more after the onset of the rash [5,6,7], whereas some use the threshold of three months [8,9] This chronic pain has a potentially high impact on the quality of life. Many patients develop severe physical, occupational, and social disabilities as a consequence of their unceasing pain [8]

Objectives

Methods

Findings

Conclusion