The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedJune 24, 2019
June 1, 2019
1 year
June 21, 2019
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 COMPARATOR0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days
N group
PLACEBO COMPARATOR0.19% Ropivacaine 8mL only every other day injection during 10 days
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. .
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
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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