NCT03995563

Brief Summary

The efficiency of epidural steroid injection in patients who has postherpetic neuralgia is well known. In this study, the purpose is whether the continous epidural steroid injection is effective or not.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

June 24, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 21, 2019

Last Update Submit

June 21, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS score

    The investigator set the primary outcome If there is a 50% reduction of VAS score.

    up to 10 days

Study Arms (2)

D group

ACTIVE COMPARATOR

0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days

Drug: DexamethasoneDrug: Ropivacaine

N group

PLACEBO COMPARATOR

0.19% Ropivacaine 8mL only every other day injection during 10 days

Drug: Ropivacaine

Interventions

Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days. .

Also known as: DEXA-S
D group

Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days

Also known as: Rocaine
D groupN group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who has herpes zoster
  • Patients has a period (at least 1month) after onset of herpes zoster
  • Patients has a definite symptom along dermatome
  • ASA class I - II
  • Age : 18 - 80 years

You may not qualify if:

  • Patients who has a cancer
  • Patients who has a neurologic, psychologic, renal, hepatic and hematologic disease
  • Patients who has a other dermatologic disease
  • Patients who has major operation \& procedure history
  • Patients who has a other pain origin
  • Patients who can not be inserted epidural catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangnam sacred heart hospital

Seoul, Yeongdeungpo-gu, 07441, South Korea

RECRUITING

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

DexamethasoneRopivacaine

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Jung Eun Kim, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 24, 2019

Study Start

May 15, 2019

Primary Completion

May 30, 2020

Study Completion

November 30, 2020

Last Updated

June 24, 2019

Record last verified: 2019-06

Locations